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Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial (THRIVE)

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The Washington University

Status

Enrolling

Conditions

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

Treatments

Other: Anesthetic technique inhaled agent
Other: Anesthetic technique Propofol TIVA

Study type

Interventional

Funder types

Other

Identifiers

NCT05991453
202304082

Details and patient eligibility

About

The investigators will conduct a 12,500-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

Enrollment

12,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

12,500 participants in 2 patient groups

Propofol total intravenous anesthesia (TIVA)
Active Comparator group
Description:
No administration of inhaled agent.
Treatment:
Other: Anesthetic technique Propofol TIVA
inhaled volatile general anesthesia (INVA)
Active Comparator group
Description:
Must administer inhaled agent.
Treatment:
Other: Anesthetic technique inhaled agent

Trial contacts and locations

20

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Central trial contact

Sherry McKinnon; Laura Swisher

Data sourced from clinicaltrials.gov

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