Clinical trial NCT05051982: Sedline EEG Guided Depth of Anesthesia
Official title: SedLine EEG-Guided Depth of Anesthesia: Effect of Anesthetic Dosage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Surgery
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 110
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Average Anesthetic
timeFrame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Secondary outcomes:
measure: Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)
timeFrame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
measure: Time Period of Hypotension
timeFrame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
measure: Total Dosage of Vasopressor (Norepinephrine, Phenylephrine)
timeFrame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
measure: Occurrence of EEG Isoelctricity
timeFrame: 5 minutes after induction until administration of neuromuscular blocker reversal drugs up to 24 hours
measure: Total Dosage of Vasopressor (Ephedrine)
timeFrame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
measure: Total Dosage of Vasopressor (Vasopressin)
timeFrame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
measure: Total Hypnotic Agents (Fentanyl)
timeFrame: 5 minutes after induction until the time which administration of neuromuscular blocker reversal drugs is given
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Timothy Webb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
citation: 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.
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.