Sedline EEG Guided Depth of Anesthesia

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05051982
• Other study ID #: 10708
• Status: Completed
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: November 14, 2022

Study information

• Verified date: January 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 14, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	IU Health University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Total Dosage of Vasopressor (Norepinephrine, Phenylephrine)	phenylephrine, norepinephrine	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Secondary	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
Secondary	Total Dosage of Vasopressor (Ephedrine)	ephedrine	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Secondary	Total Dosage of Vasopressor (Vasopressin)	vasopressin	5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Secondary	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