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NCT Number: NCT05991453

Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

The investigators will conduct a 13,000-patient randomized multi-center trial to determine (i) which general anesthesia technique yields superior patient recovery experiences in any of three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c) outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient surgeries

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Key information

Conditions

Surgery-Complications Anesthesia Anesthesia Awareness Anesthesia Complication Anesthesia Morbidity Intraoperative Awareness Intraoperative Complications Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Quality of Life Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences (UAMS), Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Each patient must meet all of the following criteria:

  • Aged 18 years or older
  • Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic device)

Exclusion criteria

Patients will not be enrolled if any of the following criteria are met:

  • Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
  • Pregnancy (based on patient report or positive test on the day of surgery)
  • Surgical procedure requiring general, regional, neuraxial anesthesia administered by an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring within 30 days prior to or planned to occur within 30 days after surgery date
  • Contraindication to propofol TIVA or INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia) based on self-report
  • Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
  • Locally approved, written protocol mandating a particular anesthetic technique
  • History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
  • Planned postoperative intubation
  • Current incarceration

Treatment and study plan

Anesthetic technique Propofol TIVA

Other

Propofol TIVA no inhaled agent

Other names: Propofol TIVA

Anesthetic technique inhaled agent

Other

Must administer inhaled agent.

Other names: Inhaled agent

Primary outcomes

  1. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery

    Time frame: Postoperative day 1

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  2. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery

    Time frame: Postoperative day 1

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  3. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery

    Time frame: Postoperative day 1

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  4. Incidence of definite intraoperative awareness with recall

    Time frame: Postoperative day 30

    The modified Brice questionnaire is used to screen for intraoperative awareness. A positive screen (a patient who reports remembering anything between going to sleep for their surgical procedure and waking up after) on the modified Brice questionnaire is followed by a structured interview. A panel of expert adjudicators determines whether or not this was definite intraoperative awareness.

Secondary outcomes

  1. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery

    Time frame: postoperative day 0

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  2. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery

    Time frame: postoperative day 0

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  3. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery

    Time frame: postoperative day 0

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  4. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery

    Time frame: postoperative day 2

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  5. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery

    Time frame: postoperative day 2

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  6. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after outpatient surgery

    Time frame: postoperative day 2

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  7. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after major inpatient surgery

    Time frame: postoperative day 7

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  8. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after minor inpatient surgery

    Time frame: postoperative day 7

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  9. Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after outpatient surgery

    Time frame: postoperative day 7

    The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.

  10. Days Alive and at Home at 30 days after major inpatient surgery

    Time frame: postoperative day 30

    Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.

  11. Days Alive and at Home at 30 days after minor inpatient surgery

    Time frame: postoperative day 30

    Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.

  12. Days Alive and at Home at 30 days after outpatient surgery

    Time frame: postoperative day 30

    Patient hospital length of stay after the surgery is documented. A patient completed survey assesses hospital re-admission since discharge from surgery and days spent in the hospital since original discharge.

  13. Incidence of delirium on postoperative day 0 after major inpatient surgery

    Time frame: postoperative day 0

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.

  14. Incidence of delirium on postoperative day 0 after minor inpatient surgery

    Time frame: postoperative day 0

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.

  15. Incidence of delirium on postoperative day 0 after outpatient surgery

    Time frame: postoperative day 0

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.

  16. Incidence of delirium on postoperative day 1 after major inpatient surgery

    Time frame: postoperative day 1

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.

  17. Incidence of delirium on postoperative day 1 after minor inpatient surgery

    Time frame: postoperative day 1

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium.

  18. Delirium Severity Score on postoperative day 0 after major inpatient surgery

    Time frame: postoperative day 0

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.

  19. Delirium Severity Score on postoperative day 0 after minor inpatient surgery

    Time frame: postoperative day 0

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.

  20. Delirium Severity Score on postoperative day 0 after outpatient surgery

    Time frame: postoperative day 0

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.

  21. Delirium Severity Score on postoperative day 1 after major inpatient surgery

    Time frame: postoperative day 1

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.

  22. Delirium Severity Score on postoperative day 1 after minor inpatient surgery

    Time frame: postoperative day 1

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The 3D-CAM severity score is calculated by adding 1 point for each positive item noted in questions 1-20. The score is calculated out of 20 points - a higher score indicates a higher severity.

  23. Incidence of Subsyndromal delirium on postoperative day 0 after major inpatient surgery

    Time frame: postoperative day 0

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.

  24. Incidence of Subsyndromal delirium on postoperative day 0 after minor inpatient surgery

    Time frame: postoperative day 0

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.

  25. Incidence of Subsyndromal delirium on postoperative day 0 after outpatient surgery

    Time frame: postoperative day 0

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.

  26. Incidence of Subsyndromal delirium on postoperative day 1 after major inpatient surgery

    Time frame: postoperative day 1

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.

  27. Incidence of Subsyndromal delirium on postoperative day 1 after minor inpatient surgery

    Time frame: postoperative day 1

    The 3D Confusion Assessment Method (3DCAM) assesses four key features of delirium. The presence of at least 1 feature is indicative of subsyndromal delirium.

  28. Health-related quality-of-life on postoperative day 30 after major inpatient surgery

    Time frame: postoperative day 30

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  29. Health-related quality-of-life on postoperative day 30 after minor inpatient surgery

    Time frame: postoperative day 30

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  30. Health-related quality-of-life on postoperative day 30 after outpatient surgery

    Time frame: postoperative day 30

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  31. Health-related quality-of-life on postoperative day 90 after major inpatient surgery

    Time frame: postoperative day 90

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  32. Health-related quality-of-life on postoperative day 90 after minor inpatient surgery

    Time frame: postoperative 90 days

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  33. Health-related quality-of-life on postoperative day 90 after outpatient surgery

    Time frame: postoperative day 90

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  34. Health-related quality-of-life on postoperative day 180 after major inpatient surgery

    Time frame: postoperative day 180

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  35. Health-related quality-of-life on postoperative day 180 after minor inpatient surgery

    Time frame: postoperative day 180

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  36. Health-related quality-of-life on postoperative day 180 after outpatient surgery

    Time frame: postoperative day 180

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  37. Health-related quality-of-life on postoperative day 365 after major inpatient surgery

    Time frame: postoperative day 365

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  38. Health-related quality-of-life on postoperative day 365 after minor inpatient surgery

    Time frame: postoperative day 365

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  39. Health-related quality-of-life on postoperative day 365 after outpatient surgery

    Time frame: postoperative day 365

    EQ-5D-5L will be used as a measure of health-related quality-of-life. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf

  40. Functional status on postoperative day 30 after major inpatient surgery.

    Time frame: postoperative day 30

    The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.

  41. Functional status on postoperative day 30, after minor inpatient surgery.

    Time frame: postoperative day 30

    The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.

  42. Functional status on postoperative day 30, after outpatient surgery.

    Time frame: postoperative day 30

    The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.

  43. Functional status on postoperative day 90 after major inpatient surgery.

    Time frame: postoperative day 90

    The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.

  44. Functional status on postoperative day 90 after minor inpatient surgery.

    Time frame: postoperative day 90

    The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.

  45. Functional status on postoperative day 90 after outpatient surgery.

    Time frame: postoperative day 90

    The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a generic assessment instrument for functional status covering 6 domains of functioning: cognition, mobility, Self-care, interacting with other people, life activities, and participation.

  46. Patient satisfaction with anesthesia on postoperative day 2

    Time frame: postoperative day 2

    The Bauer questionnaire is a patient self-reported survey assessing anesthesia-related discomfort and satisfaction with anesthesia care.

  47. Respiratory Failure on postoperative day 0

    Time frame: postoperative day 0

    Respiratory failure defined as unplanned postoperative intubation or reintubation or continued mechanical ventilation > 6 hours postoperatively. Reintubation due to reoperation is excluded.

  48. Kidney Injury on postoperative day 7

    Time frame: postoperative day 7

    Kidney Injury defined as a serum creatinine increase of 50% or 0.3 mg/dl from preoperative baseline

  49. All-Cause Mortality at POD30

    Time frame: postoperative day 30

    All-Cause Mortality at POD30

  50. All-Cause Mortality at POD90

    Time frame: postoperative day 90

    All-Cause Mortality at POD90

  51. Intraoperative Hypotension (1)

    Time frame: postoperative day 0

    Intraoperative Hypotension defined as cumulative duration of mean arterial pressure <55 mmHg for 20 minutes or greater.

  52. Intraoperative Hypotension (2)

    Time frame: postoperative day 0

    Intraoperative hypotension defined as cumulative duration of mean arterial pressure < 65 mmHg for 20 minutes or greater.

  53. Moderate or Severe Intraoperative Patient Movement

    Time frame: postoperative day 0

    Moderate or Severe Intraoperative Patient Movement is based on clinician report.

  54. Unplanned Admission After Outpatient Surgery in an Ambulatory Setting

    Time frame: postoperative days 0 and 1

    Hospital admission no later than 24 hours postoperatively after outpatient surgery in a free-standing ambulatory surgery center setting

  55. Incidence of propofol-related infusion syndrome

    Time frame: postoperative day 0

    Propofol related infusion syndrome, defined as acute refractory bradycardia in the presence of metabolic acidosis, and at least one of the following: rhabdomyolysis, acute kidney injury or hypertriglyceridemia, occurring after the start of propofol intraoperatively and within 6 hours postoperatively.

  56. Incidence of malignant hyperthermia

    Time frame: postoperative day 0

    Malignant hyperthermia, defined as unexplained muscle rigidity, tachycardia, hypercapnia, and rapidly increasing temperature leading to metabolic acidosis, rhabdomyolysis, disseminated intravascular coagulation, and ventricular arrhythmias, occurring after the start of an inhaled volatile agent intraoperatively and within 6 hours postoperatively.

Other outcomes

  1. Daily step count as measured by wearable device at baseline for those scheduled for major inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Daily step count at baseline - number of steps per day

  2. Daily step count as measured by wearable device at baseline for those scheduled for minor inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Daily step count at baseline - number of steps per day

  3. Daily step count as measured by wearable device at baseline for those scheduled for outpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Daily step count at baseline - number of steps per day

  4. Daily step count as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day

  5. Daily step count as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day

  6. Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day

  7. Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day

  8. Daily step count as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day

  9. Daily step count as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day

  10. Daily standing hours as measured by wearable device at baseline for those scheduled for major inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Daily standing hours: defined as standing hours per day

  11. Daily standing hours as measured by wearable device at baseline for those scheduled for minor inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Daily standing hours: defined as standing hours per day

  12. Daily standing hours as measured by wearable device at baseline for those scheduled for outpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Daily standing hours: defined as standing hours per day

  13. Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device.

    Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day

  14. Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device.

    Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day

  15. Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device.

    Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day

  16. Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device.

    Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day

  17. Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device.

    Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day

  18. Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device.

    Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day

  19. Total sleep time as measured at baseline by wearable device for those scheduled for outpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Total sleep time defined as minutes of total sleep time per day

  20. Total sleep time as measured at baseline by wearable device for those scheduled for major inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Total sleep time defined as minutes of total sleep time per day

  21. Total sleep time as measured at baseline by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Total sleep time defined as minutes of total sleep time per day

  22. Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day

  23. Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day

  24. Total sleep time as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day

  25. Total sleep time as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day

  26. Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day

  27. Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day

  28. Sleep onset latency as measured by wearable device at baseline for those scheduled for minor inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Sleep onset latency: defined as minutes of sleep onset latency per day

  29. Sleep onset latency as measured by wearable device at baseline for those scheduled for major inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Sleep onset latency: defined as minutes of sleep onset latency per day

  30. Sleep onset latency as measured by wearable device at baseline for those scheduled for outpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Sleep onset latency: defined as minutes of sleep onset latency per day

  31. Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day

  32. Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day

  33. Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day

  34. Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day

  35. Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day

  36. Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day

  37. Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Wake after sleep onset: defined as minutes of wake after sleep onset

  38. Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Wake after sleep onset: defined as minutes of wake after sleep onset

  39. Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Wake after sleep onset: defined as minutes of wake after sleep onset

  40. Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset

  41. Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset

  42. Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset

  43. Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset

  44. Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset

  45. Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset

  46. Sleep efficiency as measured at baseline by wearable device for those scheduled for major inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)

  47. Sleep efficiency as measured at baseline by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)

  48. Sleep efficiency as measured at baseline by wearable device for those scheduled for outpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)

  49. Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable

    Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)

  50. Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable

    Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)

  51. Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable

    Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)

  52. Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable

    Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)

  53. Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable

    Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)

  54. Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable

    Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)

  55. Midpoint of sleep as measured at baseline by wearable device for those scheduled for outpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Midpoint of sleep: defined as midpoint of sleep (time)

  56. Midpoint of sleep as measured at baseline by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Midpoint of sleep: defined as midpoint of sleep (time)

  57. Midpoint of sleep as measured at baseline by wearable device for those scheduled for major inpatient surgery.

    Time frame: 1 - 7 days prior to surgery

    Midpoint of sleep: defined as midpoint of sleep (time)

  58. Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)

  59. Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)

  60. Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 7 - 10 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)

  61. Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)

  62. Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)

  63. Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.

    Time frame: 30 - 34 days after surgery

    Measurement of outcomes will be median values measured on their wearable device

    Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Swisher

CONTACT

[email protected]

314-286-1024

Sherry McKinnon

CONTACT

[email protected]

314-286-1024

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • University of Michigan

Registry information

Acronym: THRIVE

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 14, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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