Optimizing Anesthesia to Prevent Postoperative Cognitive and Functional Decline in Older Adults: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Maximum Age: 110
Healthy Volunteers: t
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• 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

Locations
United States
Oregon
Oregon Health & Science University
RECRUITING
Portland
Contact Information
Primary
Kimberly N. Chun, BS
chunk@ohsu.edu
503-494-7437
Backup
Sarah L. Feller, BS
fellersa@ohsu.edu
503-494-6233
Time Frame
Start Date: 2023-08-14
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 260
Treatments
Active_comparator: Inhalational Anesthesia
Inhalational maintenance of anesthesia group using sevoflurane
Active_comparator: Intravenous Anesthesia
Intravenous maintenance of anesthesia group using propofol
Related Therapeutic Areas
Sponsors
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov