RecruitingNot Applicable

Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

United States13,000 participantsStarted 2023-09-13

Plain-language summary

The investigators will conduct a 13,000-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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged 18 years or older
✓. 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

✕. Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
✕. 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 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
✕. Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
✕. Locally approved, written protocol mandating a particular anesthetic technique
✕. History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
✕. Planned postoperative intubation

What they're measuring

Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery

Timeframe: Postoperative day 1

Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery

Timeframe: Postoperative day 1

Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery

Timeframe: Postoperative day 1

Incidence of definite intraoperative awareness with recall

Timeframe: Postoperative day 30

Trial details

NCT IDNCT05991453

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Laura Swisher

314-286-1024 goodl@wustl.edu

View on ClinicalTrials.gov More Surgery-Complications trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged 18 years or older
✓. 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

✕. Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
✕. 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 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
✕. Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
✕. Locally approved, written protocol mandating a particular anesthetic technique
✕. History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
✕. Planned postoperative intubation

What they're measuring

Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery

Timeframe: Postoperative day 1

Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery

Timeframe: Postoperative day 1

Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery

Timeframe: Postoperative day 1

Incidence of definite intraoperative awareness with recall

Timeframe: Postoperative day 30