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Trajectories of Recovery Afte...

Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

13000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-13

Study Completion Date

2028-07-31

Brief Summary

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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

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Detailed Description

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Conditions

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Surgery-Complications Anesthesia Complication Anesthesia Awareness Anesthesia Surgery Quality of Life Pain, Postoperative Anesthesia Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Propofol total intravenous anesthesia (TIVA)

No administration of inhaled agent.

Group Type ACTIVE_COMPARATOR

Anesthetic technique Propofol TIVA

Intervention Type OTHER

Propofol TIVA no inhaled agent

inhaled volatile general anesthesia (INVA)

Must administer inhaled agent.

Group Type ACTIVE_COMPARATOR

Anesthetic technique inhaled agent

Intervention Type OTHER

Must administer inhaled agent.

Interventions

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Anesthetic technique Propofol TIVA

Propofol TIVA no inhaled agent

Intervention Type OTHER

Anesthetic technique inhaled agent

Must administer inhaled agent.

Intervention Type OTHER

Other Intervention Names

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Propofol TIVA Inhaled agent

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers