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Recruiting Phase 4 NCT06036095

Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study

Trial Parameters

Condition Neurocognitive Disorders
Sponsor Oregon Health and Science University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 260
Sex ALL
Min Age 70 Years
Max Age 110 Years
Start Date 2023-08-14
Completion 2027-03-15
Interventions
SevofluranePropofol

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.

Eligibility 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.

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