Comparing recovery after different anesthesia techniques in surgery
Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
This study is testing whether recovery is better after surgery using either intravenous propofol or inhaled anesthesia for different types of surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 20 sites (Little Rock, Arkansas and 19 other locations) |
| Trial ID | NCT05991453 on ClinicalTrials.gov |
What this trial studies
This trial will involve 12,500 patients to compare recovery experiences between two anesthesia techniques: intravenous propofol and inhaled volatile agents. It aims to assess which method provides better outcomes across three types of surgeries: major inpatient, minor inpatient, and outpatient. Additionally, the study will evaluate the risk of intraoperative awareness associated with each technique. The research will be conducted across multiple centers to ensure a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective non-cardiac surgeries lasting at least 60 minutes requiring general anesthesia.
Not a fit: Patients who are pregnant, unable to provide informed consent, or have contraindications to the anesthesia techniques will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery experiences for patients undergoing surgery.
How similar studies have performed: Previous studies comparing anesthesia techniques have shown varying results, but this large-scale trial aims to provide more definitive conclusions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 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) Exclusion Criteria 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 possible or definite intraoperative awareness during general anesthesia based on patient self-report 8. Planned postoperative intubation 9. Current incarceration
Where this trial is running
Little Rock, Arkansas and 19 other locations
- University of Arkansas for Medical Sciences (UAMS) — Little Rock, Arkansas, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Stanford University — Stanford, California, United States (Not_yet_recruiting)
- Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham & Women's — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
- NYU Langone — New York, New York, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Wake Forest — Winston-Salem, North Carolina, United States (Recruiting)
- Oregon Health and Sciences University — Portland, Oregon, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- University of Texas - MD Anderson — Houston, Texas, United States (Recruiting)
- University of Utah - Medical — Salt Lake City, Utah, United States (Recruiting)
- UVA Health — Charlottesville, Virginia, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Sachin Kheterpal, MD — University of Michigan
- Study coordinator: Laura Swisher
- Email: goodl@wustl.edu
- Phone: 314-286-1024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.