← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline through one year

Awards & highlights

TIVA GAS Trial 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.Check my eligibility

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.See study design

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.

TIVA GAS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 75 years old or older.

Select...

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

TIVA GAS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

+1 more

TIVA GAS Trial Design

2Treatment groups

Active Control

Group I: Intravenous AnesthesiaActive Control1 Intervention

Intravenous maintenance of anesthesia group using propofol

Group II: Inhalational AnesthesiaActive Control1 Intervention

Inhalational maintenance of anesthesia group using sevoflurane

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,652 Total Patients Enrolled

Katie J. Schenning, MDPrincipal InvestigatorOregon Health and Science University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is entry into this medical trial restricted to adults only?

"This particular medical research study is targeting elderly patients between 75 and 105 years of age. By contrast, there are 68 trials that accommodate individuals below 18 and 753 for those over 65."

Answered by AI

Is this trial presently seeking new participants?

"The medical investigation has been listed on the clinicaltrials.gov website since August 14th 2023 and was recently updated on September 6th of the same year, indicating that it is still in need of participants."

Answered by AI

How many participants are included in this research endeavor?

"Affirmative. According to the clinicaltrials.gov site, this medical trial has been recruiting participants since August 14th 2023 and is still actively seeking 260 patients from a single location for enrolment."

Answered by AI

Has Inhalational Anesthesia been deemed safe by the FDA?

"The efficacy and safety of Inhalational Anesthesia has been widely established, resulting in a score of 3."

Answered by AI

What is the objective of this research endeavor?

"This clinical trial will evaluate the effects of intravenous vs. inhalational anesthesia on postoperative neurocognitive disorder and functional decline in older adults undergoing non-cardiac surgery for a duration that spans 3 days postoperatively, along with levels of blood phosphorylated tau 181 (p-tau181) at preoperative baseline as well as postoperative day 1, 3 months and 12 months. Patient-reported outcomes such as anxiety, depression, fatigue, pain interference, physical function sleep disturbance etc., assessed through PROMIS-29+2 Profile v2.1 (PROPr), are also being measured at preoperative"

Answered by AI

Would I be eligible to participate in this research experiment?

"To qualify for this medical research, candidates must be of aged between 75 and 105 with some form of neurocognitive disorder. The trial requires 260 participants in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study

Katie J. Schenning 2023. "Total Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06036095.

All > Vancouver > Mild Cognitive Impairment