Skip to main content
OpenTrials
Completed

NCT Number: NCT05051982

Sedline EEG Guided Depth of Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sedline EEG in View

Device

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

Primary outcomes

  1. Total Average Anesthetic

    Time frame: 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 outcomes

  1. Total Hypnotic Agents (Midazolam, Ketamine, Methadone, Hydromorphone)

    Time frame: 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.

  2. Time Period of Hypotension

    Time frame: 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

  3. Total Dosage of Vasopressor (Norepinephrine, Phenylephrine)

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

    phenylephrine, norepinephrine

  4. Occurrence of EEG Isoelctricity

    Time frame: 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)

  5. Total Dosage of Vasopressor (Ephedrine)

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

    ephedrine

  6. Total Dosage of Vasopressor (Vasopressin)

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

    vasopressin

  7. Total Hypnotic Agents (Fentanyl)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2021
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.