Compares treatment options for Surgery-Complications
Official title Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial
ClinicalTrials.gov ID: NCT05991453
What this study is testing
- What it's testing
- The investigators will conduct a 13,000-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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Each patient must meet all of the following criteria:
- Aged 18 years or older
- Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general anesthesia with a tracheal tube or laryngeal mask airway (or...
You likely can't join if
- Patients will not be enrolled if any of the following criteria are met:
- Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
- 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...
- Contraindication to propofol TIVA or INVA (for example, documented allergy to propofol, history of severe postoperative nausea or vomiting, concern...
- Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
See the full eligibility criteria
- Each patient must meet all of the following criteria:
- Aged 18 years or older
- 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)
- Patients will not be enrolled if any of the following criteria are met:
- Inability to provide informed consent in English (at all study sites) or Spanish (at sites where Spanish consent is provided as an option)
- 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...
- 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
- Surgical procedures requiring a specific general anesthesia technique (for example, TIVA required for neuromonitoring).
- Locally approved, written protocol mandating a particular anesthetic technique
- History of possible or definite intraoperative awareness during general anesthesia based on patient self-report
- Planned postoperative intubation
- Current incarceration
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- San Francisco, California, United States
- Stanford, California, United States
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Lebanon, New Hampshire, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; San Francisco, California, United States; Stanford, California, United States; New Haven, Connecticut, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.