Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Aug 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different types of general anesthesia used during surgery: intravenous propofol (TIVA) and inhaled volatile anesthesia (INVA). The goal is to find out which method helps patients recover better after surgery and to see if TIVA has a very small risk of causing awareness during surgery compared to INVA. The trial will involve 12,500 patients undergoing various types of surgeries, including major and minor inpatient surgeries, as well as outpatient procedures.

To participate, you must be at least 18 years old and scheduled for a non-cardiac surgery that will take at least an hour and requires general anesthesia. However, there are some reasons you may not be eligible, such as being pregnant, having certain medical conditions, or if your surgery requires a specific type of anesthesia. If you join the study, you can expect to receive one of the two anesthesia types and be part of a larger effort to improve recovery experiences for patients after surgery.

Gender

ALL

Eligibility 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