Sedline EEG Guided Depth of Anesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Anesthesia
• Intervention / Treatment: Device: Sedline EEG in View

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; 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.	Device: Sedline EEG in View; EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
No Intervention: Control Group; 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 control group, an apparatus will be placed over the monitor will not be in view of the anesthesiologist. The

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)	the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia. These agents include: midazolam, methadone, and hydromorphone.	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Time Period of Hypotension	this will be defined as an episode of mean arterial pressure of <65 mmHg	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Total Dosage of Vasopressor (Norepinephrine, Phenylephrine)	phenylephrine, norepinephrine	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Occurrence of EEG Isoelctricity	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)	5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours
Total Dosage of Vasopressor (Ephedrine)	ephedrine	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Total Dosage of Vasopressor (Vasopressin)	vasopressin	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Total Hypnotic Agents (Fentanyl)	the total dosage of hypnotic agents administered while in the maintenance phase of anesthesia; fentanyl.	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Timothy Webb, MD, Indiana University

Publications and helpful links

General Publications

• Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
• Hajat Z, Ahmad N, Andrzejowski J. The role and limitations of EEG-based depth of anaesthesia monitoring in theatres and intensive care. Anaesthesia. 2017 Jan;72 Suppl 1:38-47. doi: 10.1111/anae.13739.
• MacKenzie KK, Britt-Spells AM, Sands LP, Leung JM. Processed Electroencephalogram Monitoring and Postoperative Delirium: A Systematic Review and Meta-analysis. Anesthesiology. 2018 Sep;129(3):417-427. doi: 10.1097/ALN.0000000000002323.
• Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.
• 4. Kaplan LJ, Bailey H. Bispectral index (BIS) monitoring of ICU patients on continuous infusion of sedatives and paralytics reduces sedative drug utilization and cost.
• Ishizawa Y. Special article: general anesthetic gases and the global environment. Anesth Analg. 2011 Jan;112(1):213-7. doi: 10.1213/ANE.0b013e3181fe02c2. Epub 2010 Nov 3.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 10708 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No