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Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial

Recruiting
18 years and older
All
Phase N/A

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Overview

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

Eligibility

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 intraoperative awareness during general anesthesia based on patient self-report
  8. Planned postoperative intubation
  9. Current incarceration

Study details
    Surgery-Complications
    Anesthesia Complication
    Anesthesia Awareness
    Anesthesia
    Surgery
    Quality of Life
    Pain
    Postoperative
    Anesthesia Morbidity
    Depression
    Sleep Disorders
    Circadian Rhythm

NCT05991453

Washington University School of Medicine

28 January 2024

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FAQs

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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