BIS Monitoring in Relation to Muscle Relaxant Administration

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.

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Key information

Conditions

Cardiovascular Surgery Anesthesia Bispectral Index Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bispectral Index (BIS) monitoring system

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.

Primary outcomes

BIS Values

Time frame: 25-minute period in the operating room

Parameters measured from both left and right BIS sensors. BIS monitor algorithm to process EEG information second by second and outputs a number (0-100) that corresponds with a patient's level of consciousness. A level of 0 indicates no EEG activity; a level of 100 indicates awake EEG activity.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Effect of Timing of Commencement of Bispectral Index Monitoring in Relation to Muscle Relaxant Administration

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 30, 2022
Registry last updated: Oct 13, 2023

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.

Completed