Sedline EEG Guided Depth of Anesthesia

Not Applicable

Completed

Conditions: Surgery
Anesthesia

Interventions: Device: Sedline EEG in View

Registration Number: NCT05051982

Lead Sponsor: Indiana University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Sedline EEG in View	Prior to the induction of anesthesia, the Sedline monitor will be placed on the patient's head to ensure the monitor is working properly. For those in the study group, the monitor will be in full view of the anesthesiologist administering the anesthetic.

Primary Outcome Measures

Name	Time	Method
Total Average Anesthetic	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given	total average percent of volatile anesthetic (sevoflurane) utilized while subjects are under anesthesia (maintenance phase).

Secondary Outcome Measures

Name	Time	Method
Total Dosage of Vasopressor (Norepinephrine, Phenylephrine)	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given	phenylephrine, norepinephrine
Total Dosage of Vasopressor (Vasopressin)	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given	vasopressin
Total Hypnotic Agents (Fentanyl)	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given	the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia; fentanyl.
Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given	the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia. These agents include: midazolam, methadone, and hydromorphone.
Time Period of Hypotension	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given	this will be defined as an episode of mean arterial pressure of \<65 mmHg
Occurrence of EEG Isoelctricity	5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours	Following the procedure, images and data from the Sedline device were evaluated to determine what percentage of the case a patient's processed EEG displayed isoelectricity (burst suppression). A burst-suppression (or suppression-burst) pattern is a discontinuous EEG, with periods of marked suppression or isoelectric intervals alternating with "bursts" of activity, with or without embedded epileptiform features (Bauer et al., 2013)
Total Dosage of Vasopressor (Ephedrine)	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given	ephedrine