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Completed

NCT Number: NCT05346588

THRIVE Feasibility Trial

To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.

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Key information

Conditions

Surgery--Complications Anesthesia Anesthesia Awareness Anesthesia Complication Anesthesia Emergence Delirium Anesthesia Morbidity Behavior Behavioral Symptoms Chronobiology Disorders Confusion Delirium Depression Dyssomnias Emergence Delirium Intraoperative Awareness Intraoperative Complications Mental Disorders Nausea Nausea, Postoperative Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Occupational Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Quality of Life Signs and Symptoms Signs and Symptoms, Digestive Sleep Disorders, Circadian Rhythm Sleep Wake Disorders Surgery Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stanford University, Stanford, California, United States

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About this study

Two-center single-blinded randomized feasibility study, with randomization 1:1 to either propofol TIVA or inhaled volatile general anesthesia for patients who are receiving elective non-cardiac surgery. Patients will be stratified by clinical site with 150 participants per site.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Inability to provide informed consent in English
  • 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 inhaled volatile (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia)
  • Surgical procedures requiring specific general anesthesia option (for example, TIVA required for neuromonitoring).
  • Hospital approved, written protocol mandating a particular technique
  • History of intraoperative awareness during general anesthesia based on patient self-report on the day of consent
  • Planned postoperative intubation

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. Proportion participating

    Time frame: 8 months

    Proportion of patients who are approached to participate by the study team and who consent to participate in the study.

  2. Proportion receiving TIVA

    Time frame: 8 months

    Proportion of patients in the propofol TIVA group who receive per protocol treatment (i.e. they receive no inhaled agents as part of their anesthetic).

  3. Proportion receiving inhaled anesthesia

    Time frame: 8 months

    Proportion of patients in the inhaled volatile group who receive per protocol treatment (i.e. they do receive inhaled agents as part of their anesthetic).

Secondary outcomes

  1. Completeness of data collection

    Time frame: 11 months

    Completeness of data collection (defined as the percentage of instruments or data fields completed with at least 90% of expected forms or relevant fields completed at each time point and with each instrument)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • Stanford University
  • University of Michigan
  • University of Pennsylvania

Registry information

Official study title

Feasibility Study for the Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia (THRIVE) Trial

Acronym: THRIVE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2022
Registry last updated
Nov 24, 2023

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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