Sedline EEG Guided Depth of Anesthesia

NCT05051982 | Completed Results DMC FDA Device

• 1 other identifier: 10708
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)

  5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given

• Time Period of Hypotension

  5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given

• Total Dosage of Vasopressor (Norepinephrine, Phenylephrine)

  5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given

• Occurrence of EEG Isoelctricity

  5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours

• Total Dosage of Vasopressor (Ephedrine)

  5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given

Study Arms (2)

Study Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Sedline EEG in View DEVICE

EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.

Study Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (6)

• 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.

  PMID: 28044337 BACKGROUND

• 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.

  PMID: 29912008 BACKGROUND

• 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.

  PMID: 26275092 BACKGROUND

• 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.

  PMID: 30721296 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21048097 BACKGROUND

Results Point of Contact

• Title: Dr. Timothy Webb
• Organization: Indiana University School of Medicine (Dept of Anesthesia)

ttwebb@iu.edu

2196893636

Study Officials

• Timothy Webb, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Anesthesia

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 21, 2021
• Study Start: June 30, 2021
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)