Brain Function Monitoring During Surgery

NCT06619730 | Recruiting FDA Device

• 1 other identifier: IRB24-0454
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to gather information on the effectiveness of the Sedline Brain Function Monitor, and its use in this study to determine whether monitoring the brain activity during anesthesia will improve recovery, including earlier discharge and less side effects. Furthermore, the study team wants to determine whether males and females respond to anesthetics in a similar manner with and without brain monitoring.

Conditions

Surgery

Keywords

Brain function Monitoring

Outcome Measures

Primary Outcomes (1)

• Speed of recovery time

  The primary endpoint is the speed of recovery time, measured from the end time of the surgery, to the time of meeting the criteria for pediatric acute care unit (PACU) discharge. These criteria are lack of nausea/vomiting, grogginess and the level of pain; with 1 being no pain and 10 being severe pain.

  Up to 3 hours

Secondary Outcomes (2)

• To assess patient satisfaction with their anesthetic experience and side effects.

  Up to 1 day post surgery

• Difference in recovery times between males and females

  Up to 2 days post surgery

Study Arms (2)

Control Arm

NO INTERVENTION

Conventional method: Anesthesia will not be guided by the Sedline brain function monitor during the procedure.

Sedline Monitor Arm

ACTIVE COMPARATOR

Anesthesia care guided by Sedline brain function monitor during the procedure.

Device: Sedline Brain Function Monitor

Interventions

Sedline Brain Function Monitor DEVICE

The anesthesia provider will use the Sedline Brain Function Monitor information to affect their anesthetic dosing.

Sedline Monitor Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiology Physical Status Classification Grade of 1(normal, healthy patient) to Grade 3 (patient with severe disease)
• Between ages 18-45 years old
• Planned surgery duration between 60-240 minutes General-endotracheal-tube-anesthesia or general anesthesia with laryngeal mask airway
• Subjects capable of giving informed consent or
• Subjects who have an acceptable surrogate capable of giving consent on behalf of the subject
• All contraception methods will be allowable for any subject in this study. Participants may opt-out of a pregnancy test if they would prefer to proceed with surgery without one.
• Pregnant women will not be strictly excluded from this study if they meet all other criteria.

You may not qualify if:

• American Society of Anesthesiology Physical Status Classification Grade of 4,5,6 (diseases that are life threatening or no possibility of survival)
• Listed allergies to any commonly used anesthetic agents
• History of seizures, as a seizure while using brain monitoring may influence the anesthesia provider in a way that is not aligned with the purpose of this study
• Any patient undergoing emergency surgery, as can not be ensured that consent will be able to be properly obtained
• 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)
• Patients who receive neuraxial anesthesia or a peripheral nerve block as part of their anesthetic
• Patients who are taking gender-affirming hormonal medications, as this can affect the response to anesthetics
• The duration of surgery scheduled \<60 minutes

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Study Officials

• Zheng Xie, MD, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Xie, MD, PhD

CONTACT

773-702-2667; jxie@bsd.uchicago.edu

Al McAuley

CONTACT

773-834-3274; amcauley1@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: October 1, 2024
• Study Start: August 6, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 3, 2024

Record last verified: 2024-09

Locations

US (1)