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Recruiting NCT05991453

Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

No phase Interventional Surgery-Complications Anesthesia Complication Anesthesia Awareness Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anesthetic technique Propofol TIVA, Anesthetic technique inhaled agent.
Who it may be relevant to
Registry conditions: Surgery-Complications, Anesthesia Complication, Anesthesia Awareness, Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Other Anesthetic technique Propofol TIVA
    Propofol TIVA no inhaled agent
  • Other Anesthetic technique inhaled agent
    Must administer inhaled agent.

Primary outcome measures

  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after major inpatient surgery [Time frame: Postoperative day 1]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after minor inpatient surgery [Time frame: Postoperative day 1]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 1 after outpatient surgery [Time frame: Postoperative day 1]
  • Incidence of definite intraoperative awareness with recall [Time frame: Postoperative day 30]
Secondary outcome measures (12)
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after major inpatient surgery [Time frame: postoperative day 0]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after minor inpatient surgery [Time frame: postoperative day 0]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 0 after outpatient surgery [Time frame: postoperative day 0]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after major inpatient surgery [Time frame: postoperative day 2]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after minor inpatient surgery [Time frame: postoperative day 2]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 2 after outpatient surgery [Time frame: postoperative day 2]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after major inpatient surgery [Time frame: postoperative day 7]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after minor inpatient surgery [Time frame: postoperative day 7]
  • Patient Reported Quality of Recovery-15 (QOR15) score on postoperative day 7 after outpatient surgery [Time frame: postoperative day 7]
  • Days Alive and at Home at 30 days after major inpatient surgery [Time frame: postoperative day 30]
  • Days Alive and at Home at 30 days after minor inpatient surgery [Time frame: postoperative day 30]
  • Days Alive and at Home at 30 days after outpatient surgery [Time frame: postoperative day 30]

Eligibility criteria

Inclusion 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)

Exclusion criteria

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 within 30 days after surgery date
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 20 centers
  • University of Arkansas for Medical Sciences (UAMS) — Little Rock
  • University of California San Francisco — San Francisco
  • Stanford University — Stanford
  • Yale School of Medicine — New Haven
  • Massachusetts General Hospital — Boston
  • Brigham & Women's — Boston
  • University of Michigan — Ann Arbor
  • Henry Ford Health — Detroit
  • … and 12 more centers

Publications

  • Tellor Pennington BR, Janda AM, Colquhoun DA, Neuman MD, Kidwell KM, Spino C, Thelen-Perry S, Krambrink A, Huang S, Ignacio R, Wu Z, Swisher L, Cloyd C, Vaughn MT, Pescatore NA, Bollini ML, Mashour GA, Hassett A, Kent CD, Vlisides PE, Avidan MS, Kheterpal S; ˠTHRIVE Research Group. Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlle PMID 40953862

Identifiers

NCT: NCT05991453 · 202304082

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗