Comparing recovery after different anesthesia techniques in surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Arkansas for Medical Sciences (UAMS)
  Little Rock, Arkansas, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Yale School of Medicine
  New Haven, Connecticut, United States Recruiting
• Johns Hopkins School of Medicine
  Baltimore, Maryland, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Brigham & Women's
  Boston, Massachusetts, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.