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RecruitingAccepts healthy volunteersPhase 4

Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study

Oregon Health and Science University · NCT06036095

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 70–110 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
260
US sites recruiting
1
Study start
August 14, 2023
Record last updated
April 8, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Sevoflurane; Propofol

Conditions: Neurocognitive Disorders; Anesthesia; Post-operative Delirium; Post-operative Cognitive Dysfunction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion criteria

  • Men and women ≥ 70 years
  • Sufficient vision and hearing to complete all tests
  • Proficient in spoken and written English
  • Scheduled for elective, inpatient, noncardiac surgery, expected to last at least 120 minutes requiring general anesthesia

Exclusion criteria

  • Urgent or emergent surgery
  • Diagnosed dementia (or MoCA\<19)
  • History of Parkinson's disease, major psychiatric disease (Schizophrenia), or severe traumatic brain injury
  • Ongoing alcohol or substance abuse (per DSM V criteria)
  • Allergy to propofol or sevoflurane
  • Personal or family history of malignant hyperthermia
  • Planned postoperative intubation
  • Brain surgery
  • Surgery requiring TIVA or GAS (i.e. cases involving neuromonitoring)
  • Surgical procedure requiring general anesthetic occurring within 3 months (before or after) surgical date
  • Any patient or perioperative factor considered a contraindication to randomization to either experimental group by the surgeon or anesthesiologist.

Recruiting US locations

  • Oregon Health & Science University

    Portland, OR 97239

    Site contact: Sarah Feller, BS · fellersa@ohsu.edu

Study contacts (from the official record)

  • Kimberly N. Chun, BS · 503-494-7437 · chunk@ohsu.edu
  • Sarah L. Feller, BS · 503-494-6233 · fellersa@ohsu.edu
All healthy volunteers studies in Oregon →
Total Intravenous Versus Inhalational Anesthesia- A Geriatric… (NCT06036095) | Bored Studies