Sedline EEG Guided Depth of Anesthesia

Completed · Not applicable

Conditions studied: Anesthesia, Surgery

In brief

The purpose of our study is to determine if monitoring sedation (how asleep patients are under general anesthesia) using a device called a Sedline Monitor affects the amount of anesthesia patients receive.

Key facts

Study ID

NCT05051982

Run by

Indiana University

People needed

110

Starts

2021-06-30

Expected to finish

2022-11-14

Last updated by the study team

2024-01-16

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients undergoing a scheduled surgery (laparotomy, hepatobiliary surgery, gynecologic surgery, and/or urologic surgery procedures) at Indiana University Health University Hospital that is expected to have at least a 3 day post-operative hospital stay.
• ASA class 1, 2, 3, or 4.
• Age 65 years or older.
• Male or Female
• Surgical procedure requiring general anesthesia.

You may not qualify if…

• Any previous diagnosis of dementia or other cognitive impairment.
• Any patient undergoing emergency surgery.
• Any patient undergoing surgery who is currently an inpatient.
• Patient refusal to participate in study.
• Any patient undergoing surgery that would prevent placement of the Sedline monitor leads (for example - surgery on the patient's forehead/scalp).
• Any physical, mental, or medical conditions which, in the opinion of the investigators, may confound the ability to assess the patient for delirium in the post-operative period.

Where it is running

• IU Health University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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