Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT06036095
Phase
PHASE4
Status
Recruiting
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Conditions

  • Anesthesia
  • Neurocognitive Disorders
  • Post-operative Cognitive Dysfunction
  • Post-operative Delirium

Eligibility Criteria

Sex
ALL
Age
70 Years - 110 Years
Healthy Volunteers
Accepted

Interventions

  • Sevoflurane — DRUG
    Inhalational maintenance of anesthesia group using sevoflurane
  • Propofol — DRUG
    Intravenous maintenance of anesthesia group using propofol

Study Details

Traditionally, general anesthesia is maintained with inhalational anesthesia (GAS), but there is a gap in knowledge regarding whether intravenous anesthesia (IV) can prevent deleterious postoperative outcomes in the geriatric surgical population. The goal of this clinical trial is to determine whether intravenous anesthesia (IV) leads to a decreased incidence of postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and functional decline, and improved patient-reported outcomes (PROs) in older adults undergoing non-cardiac surgery when compared to the standard inhalational anesthesia (GAS). This single-center, 1:1 randomized, double-blind (patient \& outcome assessor) clinical trial will compare inhalational vs. intravenous anesthesia on POD, POCD, functional status, patient-reported outcomes (PROs), and blood-based biomarkers in older patients undergoing elective, inpatient, non-cardiac surgery. Upon enrollment, 260 women and men ≥ 70 years undergoing elective noncardiac surgery under general anesthesia will be randomized to 2 groups: TIVA or GAS.

Key Dates

Start date
Aug 14, 2023
Status verified
Apr 2024
Primary completion
Mar 15, 2027
Completion
Mar 15, 2027

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Inhalational Anesthesia
    Inhalational maintenance of anesthesia group using sevoflurane
  • Active Comparator: Intravenous Anesthesia
    Intravenous maintenance of anesthesia group using propofol

Primary Outcome Measure

Effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium in older surgical patients with the 3D-Confusion Assessment Method (3D-CAM-S) and the CAM-ICU-7. [ Time Frame: through postoperative day 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
Sarah Feller, BS
[email protected]
Kimberly Chun, BS
[email protected]
Katie Schenning, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Oregon Health & Science University· Portland, OR

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