NCT05051982

Sedline EEG Guided Depth of Anesthesia

SedLine EEG-Guided Depth of Anesthesia: Effect of Anesthetic Dosage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The main objective of this study is to determine if monitoring sedation using the FDA approved device, Sedline Monitor, affects the amount of anesthesia patients 65 or older receive during surgery. Reducing the anesthetic dose could result in less exposure of anesthetic medications to a high-risk patient population as well as a potential reduction in cost. Subjects will be randomized into either a control group or study group and have the Sedline Monitor placed on their head before the start of their already scheduled surgery. During the surgery, subjects in the control group will receive standard anesthesia care and the study group will receive anesthetic drug doses guided by Sedline Monitor processed EEG characteristics. When the surgery is complete, the Sedline Monitor will be removed and subject participation will be finished. The study team will also collect information about subjects from their medical records and use it for this study.

Conditions

• Anesthesia
• Surgery

Interventions

Type	Name	Description
DEVICE	Sedline EEG in View	EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-11-14
• Completion: 2022-11-14
• First posted: 2021-09-21
• Last updated: 2024-01-16
• Results posted: 2024-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study