Actively Recruiting

Phase 4
Age: 70Years - 110Years
All Genders
Healthy Volunteers
NCT06036095

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

Age: 70Years - 110Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

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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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