BIS Monitoring in Relation to Muscle Relaxant Administration

NCT ID: NCT05440058

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-26

Study Completion Date

2022-09-20

Brief Summary

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The purpose of this study is to determine the overall optimal timing of when the Bispectral Index (BIS) monitor should be started: before or after the muscle relaxant is given.

Detailed Description

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Conditions

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Cardiovascular Surgery Bispectral Index Anesthesia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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BIS Monitoring

Subjects will have BIS sensors applied to forehead

Bispectral Index (BIS) monitoring system

Intervention Type DEVICE

Left and right sensors to record EEG activity and muscle reaction to anesthesia utilized in the operating room by anesthesia providers to assess the depth of sedation in patients with anesthesia.

Interventions

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Bispectral Index (BIS) monitoring system

Left and right sensors to record EEG activity and muscle reaction to anesthesia utilized in the operating room by anesthesia providers to assess the depth of sedation in patients with anesthesia.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Undergoing elective cardiac surgery
* Muscle relaxation administration by rocuronium

Exclusion Criteria

* Patient refusal
* Pediatric patients
* Emergency procedure
* Patients with known or suspected carotid or cerebrovascular disease
* Patients with prior stroke
* Skin condition or anatomy preventing proper sensor placement
* Patients who receive ketamine during the study timeframe
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Matthew J. Ritter

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew Ritter, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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22-001485

Identifier Type: -

Identifier Source: org_study_id

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