BIS Monitoring in Relation to Muscle Relaxant Administration

Effect of Timing of Commencement of Bispectral Index 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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Bispectral Index; Cardiovascular Surgery
• Intervention / Treatment: Device: Bispectral Index (BIS) monitoring system

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing elective cardiovascular surgery, for whom BIS monitoring will be used.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BIS Monitoring; Subjects will have BIS sensors applied to forehead	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIS Values	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.	25-minute period in the operating room

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Matthew Ritter, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Actual): September 20, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Paralysis; BIS
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Muscle Hypotonia
• Other Study ID Numbers: 22-001485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No