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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Bispectral Index
• Cardiovascular Surgery
• Muscle Hypotonia

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

External Links

•   Mayo Clinic Clinical Trials