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BIS Monitoring in Relation to Muscle Relaxant Administration

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05440058
Enrollment
22
Registered
2022-06-30
Start date
2022-08-26
Completion date
2022-09-20
Last updated
2023-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Bispectral Index, Cardiovascular Surgery

Keywords

BIS, Paralysis

Brief 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.

Interventions

DEVICEBispectral 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BIS Values25-minute period in the operating roomParameters 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026