Cardiovascular SurgeryNCT05440058
BIS Monitoring in Relation to Muscle Relaxant Administration
An observational study of Cardiovascular Surgery and Bispectral Index, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Surgery, Bispectral Index, Anesthesia
- What is being tested?
- Bispectral Index (BIS) monitoring system
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2022to 20 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing elective cardiovascular surgery, for whom BIS monitoring will be used.
Who may be able to join
- Undergoing elective cardiac surgery
- Muscle relaxation administration by rocuronium
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cardiovascular Surgery, Bispectral Index, Anesthesia
- Being tested
- Bispectral Index (BIS) monitoring system
- Keywords
- BIS, Paralysis
- Medical subject headings
- Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| BIS Monitoring | Subjects will have BIS sensors applied to forehead Receives: Device: Bispectral Index (BIS) monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 25-minute period in the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start26 Aug 2022
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Ritter, Mayo Clinic
- Investigators
- Matthew Ritter, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440058
- Sponsor's protocol ID
- 22-001485
- Status last verified
- Oct 2023
- First submitted
- 27 Jun 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Timing of Commencement of Bispectral Index Monitoring in Relation to Muscle Relaxant Administration
- ClinicalTrials.gov ID
- NCT05440058
- Acronym / sponsor ID
- 22-001485
- Conditions
- Cardiovascular Surgery, Bispectral Index, Anesthesia
- Keywords
- BIS, Paralysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIS Monitoring | – | Device: Bispectral Index (BIS) monitoring systemSubjects will have BIS sensors applied to forehead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing elective cardiovascular surgery, for whom BIS monitoring will be used.
Key inclusion criteria (2 listed)
- Undergoing elective cardiac surgery
- Muscle relaxation administration by rocuronium
Key exclusion criteria (7 listed)
- Patient refusal
- Pediatric patients
- Emergency procedure
- Patients with known or suspected carotid or cerebrovascular disease
- Patients with prior stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispectral Index (BIS) monitoring systemLeft 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. | Device | BIS Monitoring |
Primary outcome
BIS Values
Time frame: 25-minute period in the operating room
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Ritter, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Surgery and Bispectral Index, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIS Values (time frame: 25-minute period in the operating room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.