Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study
Recruiting now · Phase 4
Conditions studied: Neurocognitive Disorders, Anesthesia, Post-operative Delirium, Post-operative Cognitive Dysfunction
In brief
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 facts
- Study ID
- NCT06036095
- Run by
- Oregon Health and Science University
- People needed
- 260
- Starts
- 2023-08-14
- Expected to finish
- 2027-03-15
- Last updated by the study team
- 2024-04-08
Who can join
Age: 70 and older, up to 110. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
Full record on ClinicalTrials.gov
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