THRIVE Feasibility Trial

Washington University School of Medicine300 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

300

Conditions

Surgery--Complications Anesthesia Complication Anesthesia Awareness Anesthesia Emergence Delirium Anesthesia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Stanford University

Stanford, California, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hosptial of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Proportion participating

Proportion of patients who are approached to participate by the study team and who consent to participate in the study.

Time frame: 8 months

Proportion receiving TIVA

Proportion of patients in the propofol TIVA group who receive per protocol treatment (i.e. they receive no inhaled agents as part of their anesthetic).

Time frame: 8 months

Proportion receiving inhaled anesthesia

Proportion of patients in the inhaled volatile group who receive per protocol treatment (i.e. they do receive inhaled agents as part of their anesthetic).

Time frame: 8 months

Secondary Outcomes

Completeness of data collection

Completeness of data collection (defined as the percentage of instruments or data fields completed with at least 90% of expected forms or relevant fields completed at each time point and with each instrument)

Time frame: 11 months

THRIVE Feasibility Trial

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes