Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Anesthetic technique Propofol TIVA

    Other intervention

    Propofol TIVA no inhaled agent

  • Anesthetic technique inhaled agent

    Other intervention

    Must administer inhaled agent.

Treatment groups

13,000 Participants
are divided into 2 treatment groups
Group A: Propofol total intravenous anesthesia (TIVA)Active comparator 1 intervention
Group B: inhaled volatile general anesthesia (INVA)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Postoperative day 1
2

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.

Time frame
Postoperative day 1
3

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.

Time frame
Postoperative day 1
4

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.

Time frame
Postoperative day 30

Secondary outcomes

1

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.

Time frame
postoperative day 0
2

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.

Time frame
postoperative day 0
3

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.

Time frame
postoperative day 0
4

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.

Time frame
postoperative day 2

Other outcomes

1

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

Time frame
1 - 7 days prior to surgery
2

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

Time frame
1 - 7 days prior to surgery
3

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

Time frame
1 - 7 days prior to surgery
4

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

Time frame
7 - 10 days after surgery

Sponsors and contacts

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Washington University School of Medicine

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

University of Michigan

Collaborator