Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study

NCT06036095 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00024667
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Disorders; Anesthesia; Post-operative Delirium; Post-operative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

• Effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium in older surgical patients with the 3D-Confusion Assessment Method (3D-CAM-S) and the CAM-ICU-7.

  Incidence of postoperative delirium with the 3D-Confusion Assessment Method (3D-CAM) in non-intubated patients and the CAM-ICU-7 in intubated patients. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3 while the patient is in the hospital.

  through postoperative day 3

• Determine the effects of intravenous vs. inhalational anesthesia on the incidence of postoperative neurocognitive disorder in older adults undergoing non-cardiac surgery using neuropsychiatric composite score.

  Postoperative neurocognitive disorder. Change from preoperative baseline cognitive dysfunction using neuropsychiatric composite score. Battery of neuropsychological tests: Animal Verbal Fluency Test, Trail Making Test A \& B, Digit Symbol Test, Logical Memory Immediate \& Delayed Recall, and CERAD Word List Immediate and Delayed recall. MASQ will be used for subjective cognitive decline. Functional status will be measured by FAQ.

  Change from preoperative baseline to one year.

Secondary Outcomes (4)

• Determine the effects of intravenous vs. inhalational anesthesia on incidence of delirium duration (days) and severity, measured by 3D-CAM-S, and CAM-ICU-7 in older adults undergoing non-cardiac surgery.

  through postoperative day 3

• Effects of intravenous vs. inhalational anesthesia on levels of blood phosphorylated tau 181 (p-tau181) in older surgical patients.. Change from preoperative baseline blood p-tau181 to postoperative day 1, 3 months and 12 months.

  Change from baseline through one year.

• Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative functional decline using ADL, FAQ, and FRAIL in older adults undergoing non-cardiac surgery.

  Change from baseline through one year

• Determine the effects of intravenous vs. inhalational anesthesia on patient-reported outcomes (PROMIS-29+2 Profile v2.1) in older adults undergoing non-cardiac surgery.

  Change from baseline through one year

Study Arms (2)

Inhalational Anesthesia

ACTIVE COMPARATOR

Inhalational maintenance of anesthesia group using sevoflurane

Drug: Sevoflurane

Intravenous Anesthesia

ACTIVE COMPARATOR

Intravenous maintenance of anesthesia group using propofol

Drug: Propofol

Interventions

Sevoflurane DRUG

Inhalational maintenance of anesthesia group using sevoflurane

Also known as: Inhalational Anesthesia

Inhalational Anesthesia

Propofol DRUG

Intravenous maintenance of anesthesia group using propofol

Also known as: Intravenous Anesthesia

Intravenous Anesthesia

Eligibility Criteria

• Age: 70 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders; Emergence Delirium

Interventions

Sevoflurane; Propofol; Anesthesia, Intravenous

Condition Hierarchy (Ancestors)

Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Anesthesia; Anesthesia and Analgesia

Study Officials

• Katie J. Schenning, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly N. Chun, BS

CONTACT

503-494-7437; chunk@ohsu.edu

Sarah L. Feller, BS

CONTACT

503-494-6233; fellersa@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This single-center, 1:1 randomized, double-blind (patient \& outcome assessor) clinical trial will compare inhalational (sevoflurane) vs. intravenous (propofol) anesthesia on POD, POCD, functional status, PROs, and biomarkers in patients ≥ 70 years undergoing elective, inpatient, non-cardiac surgery at Oregon Health \& Science University.

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: September 13, 2023
• Study Start: August 14, 2023
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)