About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Anesthetic technique Propofol TIVA
Other interventionPropofol TIVA no inhaled agent
Anesthetic technique inhaled agent
Other interventionMust administer inhaled agent.
Treatment groups
Trial outcomes
Primary outcomes
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Incidence of definite intraoperative awareness with recall
The modified Brice questionnaire is used to screen for intraoperative awareness. A positive screen (a patient who reports remembering anything between going to sleep for their surgical procedure and waking up after) on the modified Brice questionnaire is followed by a structured interview. A panel of expert adjudicators determines whether or not this was definite intraoperative awareness.
Secondary outcomes
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery
The QOR15 instrument measures quality of recovery with a score of 0 - 150 points where the higher the score the better quality of recovery.
Other outcomes
Daily step count as measured by wearable device at baseline for those scheduled for major inpatient surgery.
Daily step count at baseline - number of steps per day
Daily step count as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
Daily step count at baseline - number of steps per day
Daily step count as measured by wearable device at baseline for those scheduled for outpatient surgery.
Daily step count at baseline - number of steps per day
Daily step count as measured by wearable device for those scheduled for outpatient surgery.
Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
Sponsors and contacts
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Washington University School of Medicine
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
University of Michigan
Collaborator