Recruiting

Total Intravenous & Inhalational

Sponsor:

Oregon Health and Science University

Code:

NCT06036095

Conditions

Neurocognitive Disorders

Anesthesia

Post-operative Delirium

Post-operative Cognitive Dysfunction

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Accepted

Interventions

Sevoflurane

Propofol

Study Details

Brief summary:

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.

Conditions

Neurocognitive Disorders

Anesthesia

Post-operative Delirium

Post-operative Cognitive Dysfunction

Study ID

NCT06036095

Start date

Aug 14, 2023

Status verified date

Apr, 2024

Completion date

Mar 15, 2027

Anticipated

Primary completion date

Mar 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Inhalational Anesthesia

Inhalational maintenance of anesthesia group using sevoflurane

active comparator: Intravenous Anesthesia

Intravenous maintenance of anesthesia group using propofol

Interventions

Sevoflurane

Inhalational maintenance of anesthesia group using sevoflurane

Propofol

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 ]
  • Determine the effects of intravenous vs. inhalational anesthesia on the incidence of postoperative neurocognitive disorder in older adults undergoing non-cardiac surgery using neuropsychiatric composite score. [ Time Frame: Change from preoperative baseline to one year. ]

Central Contacts and Locations

Central contacts

Kimberly N. Chun, BS

503-494-7437chunk@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Sarah Feller, BS

fellersa@ohsu.edu

Kimberly Chun, BS

chunk@ohsu.edu

Principal Investigator:

Katie Schenning, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 8, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-04-08.