Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Lee-lynn Chen, MDMatthieu Legrand, MDJeremy Juang, MDJennifer Woodbury, MD
Headshot of Matthieu Legrand
Matthieu Legrand

Description

Summary

The investigators will conduct a 12,500-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

Keywords

Surgery-Complications, Anesthesia Complication, Anesthesia Awareness, Anesthesia, Surgery, Quality of Life, Pain, Postoperative, Anesthesia Morbidity, Depression, Sleep Disorders, Circadian Rhythm, Sleep Wake Disorders, Circadian Rhythm Sleep Disorders, Postoperative Pain, Intraoperative Awareness, Propofol, Anesthetics, Anesthetic technique Propofol TIVA, Anesthetic technique inhaled agent, Propofol total intravenous anesthesia (TIVA), inhaled volatile general anesthesia (INVA)

Eligibility

You can join if…

Open to people ages 18 years and up

Each patient must meet all of the following criteria:

  1. Aged 18 years or older
  2. 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)

You CAN'T join if...

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

  1. Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
  2. Pregnancy (based on patient report or positive test on the day of surgery)
  3. 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
  4. 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
  5. Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
  6. Locally approved, written protocol mandating a particular anesthetic technique
  7. History of intraoperative awareness during general anesthesia based on patient self-report
  8. Planned postoperative intubation
  9. Current incarceration

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Stanford University not yet accepting patients
    Stanford California 94305 United States
  • University of Utah - Medical accepting new patients
    Salt Lake City Utah 84132 United States

Lead Scientists at UCSF

  • Lee-lynn Chen, MD
  • Matthieu Legrand, MD
    Dr. Legrand is a clinician scientist practicing critical care medicine and anesthesiology. His professional interests include diagnosing and optimum treatments of shock, the diagnosis, pathophysiology, and treatment of acute kidney injury and outcomes after major surgery and critical illness.
  • Jeremy Juang, MD
  • Jennifer Woodbury, MD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Washington University School of Medicine
ID
NCT05991453
Study Type
Interventional
Participants
Expecting 12500 study participants
Last Updated