THRIVE Feasibility Trial

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

Detailed Description
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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.

Official Title
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Feasibility Study for the Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia (THRIVE) Trial

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

Intervention / Treatment
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* Other: Anesthetic technique Propofol TIVA
* Other: Anesthetic technique inhaled agent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propofol total intravenous anesthesia (TIVA)<br>No administration of inhaled agent. | Other: Anesthetic technique Propofol TIVA<br>* Propofol TIVA no inhaled agent<br>* Other names: Propofol TIVA;|
| Active Comparator: Inhaled volatile general anesthesia<br>Must administer inhaled agent. | Other: Anesthetic technique inhaled agent<br>* must administer inhaled agent.<br>* Other names: Inhaled agent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion participating | Proportion of patients who are approached to participate by the study team and who consent to participate in the study. | 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). | 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). | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 11 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of recovery, Intraoperative awareness