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NCT05440058 Clinical Trial

BIS Monitoring in Relation to Muscle Relaxant Administration

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05440058
Other study ID # 22-001485
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 26, 2022
Est. completion date September 20, 2022

Study information
Verified date October 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date September 20, 2022
Est. primary completion date September 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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