Anesthesia, Anesthesia Awareness, Anesthesia Complication, Anesthesia Emergence Delirium, Anesthesia Morbidity, Depression, Nausea, Postoperative, Pain, Postoperative, Quality of Life, Sleep Disorders, Circadian Rhythm, Surgery, Surgery--Complications
Conditions
Keywords
Quality of recovery, Intraoperative awareness
Brief summary
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
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.
Interventions
Propofol TIVA no inhaled agent
must administer inhaled agent.
Sponsors
University of Michigan
University of Pennsylvania
Stanford University
Patient-Centered Outcomes Research Institute
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion participating | 8 months | Proportion of patients who are approached to participate by the study team and who consent to participate in the study. |
| Proportion receiving TIVA | 8 months | 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). |
| Proportion receiving inhaled anesthesia | 8 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of data collection | 11 months | 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) |
Countries
United States
Outcome results
None listed