THRIVE Feasibility Trial

The Washington University

Status and phase: Completed; Phase 3

Conditions: Surgery; Surgery--Complications; Pain, Postoperative; Anesthesia Awareness; Anesthesia Emergence Delirium; Anesthesia Complication; Anesthesia Morbidity; Quality of Life; Sleep Disorders, Circadian Rhythm; Depression; Nausea, Postoperative; Anesthesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05346588

202205053

Details and patient eligibility

About

To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.

Full description

Two-center single-blinded randomized feasibility study, with randomization 1:1 to either propofol TIVA or inhaled volatile general anesthesia for patients who are receiving elective non-cardiac surgery. Patients will be stratified by clinical site with 150 participants per site.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia, including a tracheal tube or laryngeal mask airway (or similar supra-glottic device)

Exclusion criteria

• Inability to provide informed consent in English
• 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 inhaled volatile (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern for or history of malignant hyperthermia)
• Surgical procedures requiring specific general anesthesia option (for example, TIVA required for neuromonitoring).
• Hospital approved, written protocol mandating a particular technique
• History of intraoperative awareness during general anesthesia based on patient self-report on the day of consent
• Planned postoperative intubation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 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

Active Comparator group

Description:

Must administer inhaled agent.

Treatment:

Other: Anesthetic technique inhaled agent