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Intravenous Anesthetic

Inhalational vs Intravenous Anesthesia for Surgery Patients (TIVA GAS Trial)

Phase 4

Recruiting

Led By Katie J. Schenning, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women ≥ 75 years

Scheduled for elective, inpatient, noncardiac surgery, expected to last at least 120 minutes requiring general anesthesia

Must not have

Surgery requiring TIVA or GAS (i.e. cases involving neuromonitoring)

History of stroke, Parkinson's disease, major psychiatric disease (Schizophrenia), or severe traumatic brain injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline through one year.

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial compares the effects of two types of anesthesia on outcomes for elderly surgery patients. It will look at postoperative delirium, cognitive dysfunction, functional decline, patient-reported outcomes, and more.

Who is the study for?

This trial is for men and women aged 75 or older who are proficient in English, scheduled for elective non-cardiac surgery lasting at least 2 hours under general anesthesia. They must have good vision and hearing, an informant to verify their cognitive status, and no recent surgeries. Excluded are those with urgent surgeries, certain medical conditions like dementia or major psychiatric diseases, allergies to the study drugs, or a history of substance abuse.

What is being tested?

The trial aims to see if intravenous anesthesia (IV) with Propofol is better than inhalational anesthesia (GAS) with Sevoflurane in reducing postoperative delirium and cognitive dysfunction among older adults after non-cardiac surgery. It's a single-center study where participants are randomly assigned to one of the two groups in a double-blind fashion.

What are the potential side effects?

Possible side effects from Sevoflurane may include nausea, vomiting, throat irritation while Propofol can cause low blood pressure, pain at injection site or allergic reactions. Both can potentially affect memory or cognition especially in the elderly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 75 years old or older.

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I am scheduled for a major surgery that is not heart-related, will last at least 2 hours, and needs general anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need surgery that requires being fully asleep with special monitoring.

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I have had a stroke, Parkinson's, major psychiatric disease, or severe brain injury.

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I have had brain surgery.

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I or my family have a history of malignant hyperthermia.

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I need surgery urgently or as an emergency.

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I will be on a breathing machine after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline through one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline through one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline through one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

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.

Secondary study objectives

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.

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.

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.

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