Bispectral Index and Neurmuscular Monitoring Data in Anesthetized PatientsNCT04394364

Analysis and Record Intraoperative Bispectral Index of Patients of Thoracic Surgeries

An observational study of Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Bispectral index(BIS) is commonly used to monitor the depth of anesthesia. The electroencephalographic signal is collected and analyzed by the device, resulting a number related to the awareness of the patient. Electromyography is also recorded. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients
What is being tested?: Bispectral index
Type of treatment: Medical device
How many people: 100 participants
Where: 1 siteTaiwan
Study dates: 1 Jun 2020to 1 Mar 2021
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients undergoing chest surgeries

Who may be able to join

ASA class between 1 and 3
Patients scheduled for chest surgery

Who cannot join

Neuromuscular diseases
Mental and psychiatric disturbance
ASA class over 4
Drug abuse
Aboriginals

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, 112

Other trials in Taiwan

About this study

Conditions: Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients
Being tested: Bispectral index

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bispectral indexDevice
The BIS monitor will be attached to patients' forehead before anesthetized and kept until the end of the surgery

Study groups in NCT04394364
Study group	Role	What they receive
BIS monitor group		Patients under monitoring of BIS Receives: Device: Bispectral index

What is being measured

The primary outcome is the main question the study is designed to answer.

Establishing the predicting model of intraoperative electromyographics of BIS monitor and train-of-four of neuromuscular transmission monitor
We will collect EMG activity of bispectral index and train-of-four/count of neuromuscular trasmission monitor in patients undergoing pulmonary surgeries. Total intravenous anesthesia will be given to all included patients, and data will be collected since the induction of anesthesia until extubation of endotracheal tube.By statistical methods, we expect to establish the model predicting intraoperative neuromuscular blockade by EEG activity of BIS monitor.
Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20201 Mar 2021

First posted19 May 2020
Study start1 Jun 2020 (estimated)
Primary completion1 Dec 2020 (estimated)
Study completion1 Mar 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bispectral Index and Neurmuscular Monitoring Data in Anesthetized PatientsStudies of the same condition, open and under way.
More trials run by Taipei Veterans General Hospital, TaiwanThe 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: Cohort
Time perspective: Prospective
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04394364
Sponsor's protocol ID: 2020-02-018AC
Status last verified: May 2020
First submitted: 3 Mar 2020
Last updated: 19 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: No individual participant data will be shared to other researchers

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analysis and Record Intraoperative Bispectral Index of Patients of Thoracic Surgeries
ClinicalTrials.gov ID: NCT04394364
Acronym / sponsor ID: 2020-02-018AC
Conditions: Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients
Study type: Observational
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Taipei Veterans General Hospital, TaiwanOther government
Study start: 1 Jun 2020 (estimated)
Primary completion: 1 Dec 2020 (estimated)
Study completion: 1 Mar 2021 (estimated)
First posted: 19 May 2020 (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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
BIS monitor group	–	Device: Bispectral indexPatients under monitoring of BIS

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients undergoing chest surgeries

Key inclusion criteria (2 listed)

ASA class between 1 and 3
Patients scheduled for chest surgery

Key exclusion criteria (5 listed)

Neuromuscular diseases
Mental and psychiatric disturbance
ASA class over 4
Drug abuse
Aboriginals

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 indexThe BIS monitor will be attached to patients' forehead before anesthetized and kept until the end of the surgery	Device	BIS monitor group

Primary outcome

Establishing the predicting model of intraoperative electromyographics of BIS monitor and train-of-four of neuromuscular transmission monitor
Time frame: six months
We will collect EMG activity of bispectral index and train-of-four/count of neuromuscular trasmission monitor in patients undergoing pulmonary surgeries. Total intravenous anesthesia will be given to all included patients, and data will be collected since the induction of anesthesia until extubation of endotracheal tube.By statistical methods, we expect to establish the model predicting intraoperative neuromuscular blockade by EEG activity of BIS monitor.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
Individual participant dataSharing planned: No. No individual participant data will be shared to other researchers

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Bispectral Index and Neurmuscular Monitoring Data in Anesthetized Patients, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

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 5 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: status not confirmed, as of the sponsor's last update on 19 May 2020. 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 Taiwan. 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?

Results are not available in the source record.

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?

Establishing the predicting model of intraoperative electromyographics of BIS monitor and train-of-four of neuromuscular transmission monitor (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04394364.

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 19 May 2020.