NCT05440058

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 26, 2022

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

25 days

First QC Date

June 27, 2022

Last Update Submit

October 11, 2023

Conditions

Cardiovascular SurgeryBispectral IndexAnesthesia

Keywords

BISParalysis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

BIS Monitoring

Subjects will have BIS sensors applied to forehead

Device: Bispectral Index (BIS) monitoring system

Interventions

Bispectral Index (BIS) monitoring systemDEVICE

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.

BIS Monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Undergoing elective cardiac surgery
  • Muscle relaxation administration by rocuronium

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Paralysis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew Ritter, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

August 26, 2022

Primary Completion

September 20, 2022

Study Completion

September 20, 2022

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)