Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Purpose

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

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Propofol total intravenous anesthesia (TIVA) 		No administration of inhaled agent.
  • Other: Anesthetic technique Propofol TIVA
    Propofol TIVA no inhaled agent
    Other names:
    • Propofol TIVA
Active Comparator
inhaled volatile general anesthesia (INVA) 		Must administer inhaled agent.
  • Other: Anesthetic technique inhaled agent
    Must administer inhaled agent.
    Other names:
    • Inhaled agent

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Amit Bardia, MD
abardia@mgb.org

More Details

Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Laura Swisher
314-286-1024
goodl@wustl.edu