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Completed

NCT Number: NCT03133845

Shaping Anesthetic Techniques to Reduce Post-operative Delirium

The purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults.

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Key information

Conditions

Delirium Arthritis Bone Diseases Confusion Joint Diseases Lumbar Osteoarthritis Lumbar Radiculopathy Lumbar Spine Disc Degeneration Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Neuromuscular Diseases Osteoarthritis Osteoarthritis, Spine Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Rheumatic Diseases Signs and Symptoms Spinal Diseases Spondylarthritis Spondylitis

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

About this study

Post-operative delirium is a common occurrence in older adults. Post -operative delirium has been associated with cognitive decline after hospitalization. Developing perioperative management strategies to prevent delirium may also reduce potential cognitive decline in older adults after surgery. The choice and dose of anesthetic and sedative drugs are known risk factors in the development of delirium. Excessive doses of anesthetic and sedation drugs during surgery have been associated with poor outcomes that occur after surgery. Currently depth of anesthesia can be measured by an additional monitoring technique called Bispectral Index (BIS).

The purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults. Previous studies have shown that using light sedation and spinal anesthesia during surgery may reduce the incidence of delirium up to 50%.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients age 65 and over.
  • Patients undergoing lumbar fusion performed by Dr. Charles Edwards II, Dr. Charles Edwards, Dr. Clayton Dean , or Dr. Justin Park at Mercy Medical Center.
  • Expected length of surgery <3 hours.
  • Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion criteria

  • Contradictions to spinal anesthesia (severe aortic stenosis, anti-coagulant or antiplatelet medications, other)
  • Body mass index > 40 kg/m2
  • prior lumbar fusion from L2-L5 in entirety
  • Communication issues precluding delirium assessment or sedation
  • Dementia or mini-mental status exam score < 24
  • Psychiatric disease that would preclude cooperation with sedation with spinal anesthesia
  • Any other reason that the attending anesthesiologist or surgeon feels that clinical circumstances dictate a strong preference for either spinal or general anesthesia.
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Treatment and study plan

Light sedation with propofol

Procedure

Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.

Induction with propofol

Procedure

Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.

Maintenance anesthetic using a volatile anesthetic

Procedure

Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.

Muscle relaxant during maintenance anesthesia

Procedure

Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.

Pain control with fentanyl

Procedure

Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.

Bispectral Index (BIS) monitoring for depth of anesthesia

Procedure

All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.

Spinal anesthesia

Procedure

Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.

Midazolam administered during spinal anesthesia

Procedure

Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.

Cerebrospinal fluid collection

Procedure

8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.

Administration of intrathecal morphine

Procedure

Patient may receive intrathecal morphine for post-operative pain control.

Primary outcomes

  1. Incidence of delirium

    Time frame: First 3 postoperative days

    The patient will be assessed for delirium using the Confusion Assessment Method on each of the first 3 post-operative days.

Secondary outcomes

  1. Assessment of cognitive status at 3 months using the Verbal Fluency Test

    Time frame: 3 months after surgery

    The participant will be administered the Verbal Fluency Test to measure verbal fluency. Participants are given 1 minute to name as many words as possible beginning with a letter. Participants are then given 1 minute to name as many words as possible beginning with a different letter. Participants are then given 1 minute to name as many words as possible in a category. The score is the total number of different words produced for all 3 trials and will be compared to the score obtained at baseline.

  2. Assessment of cognitive status at 1 year using the Verbal Fluency test.

    Time frame: 1 year after surgery

    The participant will be administered the Verbal Fluency Test to measure verbal fluency. Participants are given 1 minute to name as many words as possible beginning with a letter. Participants are then given 1 minute to name as many words as possible beginning with a different letter. Participants are then given 1 minute to name as many words as possible in a category. The score is the total number of different words produced for all 3 trials and will be compared to the score obtained at baseline.

  3. Assessment of functional status at 3 months using the Instrumental Activities of Daily Living (IADL) test.

    Time frame: 3 months after surgery

    At 3 months, the participant's functional status will be assessed using the instrumental activities of daily living (IADL) scales. Scores can range from 0-14 with 14 being high functioning and 0 being low functioning. This score will be compared to the baseline score.

  4. Assessment of functional status at 1 year using the Instrumental Activities of Daily Living (IADL) test.

    Time frame: 1 year after surgery

    At 1 year, the participant's functional status will be assessed using the instrumental activities of daily living (IADL) scales. Scores can range from 0-14 with 14 being high functioning and 0 being low functioning. This score will be compared to the baseline score.

  5. Assessment of functional status at 3 months using the Short Form 12 Health Survey (SF-12)

    Time frame: 3 months after surgery

    This is a survey that measures the patient's own self reported view on their health. Scores range from 0-100, with 0 indicating the lowest level of health and 100 indicating the highest level of health.

  6. Assessment of functional status using at 1 year the Short Form 12 Health Survey (SF-12)

    Time frame: 1 year after surgery

    This is a survey that measures the patient's own self reported view on their health. Scores range from 0-100, with 0 indicating the lowest level of health and 100 indicating the highest level of health.

  7. Assessment of functional status at 3 months using the Oswestry Disability Index (ODI)

    Time frame: 3 months after surgery

    This survey measures self-reported disability due to low pain. Scores range from 0-100, with 0 being minimal or no disability and 100 being severe disability. This score will be compared to the baseline score.

  8. Assessment of functional status at 1 year using the Oswestry Disability Index (ODI)

    Time frame: 1 year after surgery

    This survey measures self-reported disability due to low pain. Scores range from 0-100, with 0 being minimal or no disability and 100 being severe disability. This score will be compared to the scores obtained at baseline and 3 months after surgery.

  9. Assessment of cognitive status at 3 months using Trail Making Test

    Time frame: 3 months after surgery

    This test provides information visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. The test is scored by the amount of time it takes to complete the test in seconds. This score will be compared to the score obtained at baseline.

  10. Assessment of cognitive status at 1 year using Trail Making Test

    Time frame: 1 year after surgery

    This test provides information visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. The test is scored by the amount of time it takes to complete the test in seconds. This score will be compared to the scores obtained at baseline and 1 year after surgery.

  11. Assessment of cognitive status at 3 months using the Digit Span

    Time frame: 3 months after surgery

    The Digit Span is used to measure the participant's memory span and number storage capacity. The scores range from 0-9 with 0 being short term memory impairment and 9 be no short term memory impairment. This score will be compared to the score obtained at baseline.

  12. Assessment of cognitive status at 1 year using the Digit Span

    Time frame: 1 year after surgery

    The Digit Span is used to measure the participant's memory span and number storage capacity. The scores range from 0-9 with 0 being short term memory impairment and 9 be no short term memory impairment. This score will be compared to the scores obtained at baseline and 3 months after surgery.

  13. Assessment of the cognitive status at 3 months using the Mini Mental Status Exam

    Time frame: 3 months after surgery

    The mini mental status exam measures cognitive impairment. Scores range from 0-30 with 0 being severe cognitive impairment and 30 being no cognitive impairment. This score will be compared to the score obtained at baseline.

  14. Assessment of the cognitive status at 1 year using the Mini Mental Status Exam

    Time frame: 1 year after surgery

    The mini mental status exam measures cognitive impairment. Scores range from 0-30 with 0 being severe cognitive impairment and 30 being no cognitive impairment. The score obtained will be compared to the scores obtained at baseline and 3 months after surgery.

  15. Assessment of cognitive status at 3 months after surgery using the Telephone Interview for Cognitive Status (TICS)

    Time frame: 3 months after surgery

    The telephone interview for cognitive status will only be used it the study team is unable to conduct the mini mental status exam in person. This test assesses cognitive function with scores ranging from 0-40 with 0 being severe cognitive impairment and 41 being no cognitive impairment.

  16. Assessment of cognitive status at 1 year using the Telephone Interview for Cognitive Status (TICS)

    Time frame: 1 year after surgery

    The telephone interview for cognitive status will only be used it the study team is unable to conduct the mini mental status exam in person. This test assesses cognitive function with scores ranging from 0-40 with 0 being severe cognitive impairment and 41 being no cognitive impairment.

  17. Maximum severity of delirium during hospital stay

    Time frame: Through the end of hospitalization, up to 3 months

    The patient will be assessed for delirium using the maximum total score on the Delirium Rating Scale-Revised 1998. The scale range is 0-32, with 0 being low delirium severity and 32 being high delirium severity.

  18. Number of participants with hospital readmissions within 30 days of discharge

    Time frame: 30 days from hospital discharge

    Hospital readmissions will be measured.

  19. Number of participants with emergency room visit within 30 days of hospital discharge

    Time frame: 30 days from hospital discharge

    Emergency Room Visits will be measured.

  20. Number of days in hospital after surgery

    Time frame: Immediately after surgery until discharge, up to 3 months

    The number of days in hospital after surgery will be calculated for each patient.

  21. Last pain score in the post-anesthesia care unit

    Time frame: Immediately before leaving the post-anesthesia care unit, up to 1 day

    The last pain score on the NRS pain scale of 0-10 taken in the post-anesthesia care unit by the post-anesthesia care unit staff. For this scale, 0 indicates no pain and 10 indicates the most severe pain.

  22. Total morphine equivalents of opioids given in the post-anesthesia care unit

    Time frame: During post-anesthesia care unit stay, up to 1 week

    The total amount of opioids given to each patient in the post-anesthesia care unit will be converted to morphine equivalents for each patient.

  23. Time first opioid given in the post-anesthesia care unit

    Time frame: The time the first opioid medication is given to the patient in the post-anesthesia care unit, up to 1 week

    The time will be noted when the first opioid is given to each participant in the post-anesthesia care unit.

  24. Last pain score prior to hospital discharge

    Time frame: Immediately before hospital discharge

    The last pain score recorded for each participant on the NRS pain scale of 0-10. For this scale, 0 indicates no pain and 10 indicates the most severe pain.

  25. Total amount of morphine equivalents during hospital stay

    Time frame: Duration of the hospital length of stay, up to 3 months

    The total amount of morphine equivalents will be measure for each participants hospital stay. The amount measured will be pro-rated tp the participant's length of stay.

  26. The average pain score at 3 month follow-up

    Time frame: one week prior to end of 3 month follow-up

    The average pain score for each participant on the NRS pain scale of 0-10 over the week prior to the 3 month follow-up. These score are compared to scores from baseline assessments. For this scale, 0 indicates no pain and 10 indicates the most severe pain.

  27. The average pain score at 12 month follow-up

    Time frame: one week prior to end of 12 month follow-up

    The average pain score for each participant on the NRS pain scale of 0-10 over the week prior to the 12 month follow-up. These score are compared to scores from baseline assessments. For this scale, 0 indicates no pain and 10 indicates the most severe pain.

  28. Number of days with delirium

    Time frame: Duration of the hospital stay, up to 3 months

    The number of days with delirium will measured for each participant during the length of the hospital stay for each participant.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Mercy Medical Center

Registry information

Acronym: SHARP

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2017
Registry last updated
Jun 18, 2020

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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