Actively Recruiting
Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study
Led by Oregon Health and Science University · Updated on 2024-04-08
260
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 70 years and older
- Have 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 under general anesthesia
You will not qualify if you...
- Urgent or emergent surgery
- Diagnosed dementia or Montreal Cognitive Assessment score less than 19
- History of Parkinson's disease, major psychiatric disease (schizophrenia), or severe traumatic brain injury
- Ongoing alcohol or substance abuse according to DSM V criteria
- Allergy to propofol or sevoflurane
- Personal or family history of malignant hyperthermia
- Planned postoperative intubation
- Brain surgery
- Surgery requiring total intravenous anesthesia or general anesthesia with sevoflurane due to neuromonitoring
- Surgical procedure requiring general anesthetic occurring within 3 months before or after the surgical date
- Any patient or perioperative factor considered a contraindication to randomization by surgeon or anesthesiologist
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
K
Kimberly N. Chun, BS
CONTACT
S
Sarah L. Feller, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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