BISNCT06255236
Pediatric Frontal and Nasal Bispectral Index
A study testing Bispectral index (BIS) in people with BIS, run by Mahidol University at 1 site in Thailand.
Trial summary
To compare the accuracy of frontal versus nasal BIS monitoring in pediatric patients under general anesthesia. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- BIS
- What is being tested?
- Bispectral index (BIS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 3 May 2024to 15 Nov 2024
- Phase
- Interventional
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients undergoing general anesthesia
- American Society of Anesthesiologists physical status 1-3
Who cannot join
- Patients with neurological diseases
- Patients who are using anticonvulsant drugs
- Patients who is expected to be intubated and return to the pediatric intensive care unit
- Patients undergoing head and face surgery
- Patients undergoing surgery in the prone position
- Patients who have contraindications to sevoflurane, thiopental, fentanyl, and cisatracurium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Accuracy of Bispectral Index Monitoring in an Alternative Nasal Position Compared With Standard Frontal Position in Pediatric Patients Under General Anesthesia With Sevoflurane
To compare the accuracy of frontal versus nasal BIS monitoring in pediatric patients under general anesthesia.
Read the detailed description
Standard position of frontal bispectral index (BIS) may not be available in some operations that frontal area is occupied by surgical field. This prospective cohort study aims to compare the accuracy of the BIS between an alternative position across the nasal area with the standard frontal BIS position in pediatric patients undergoing general anesthesia.
- Conditions
- BIS
- Being tested
- Bispectral index (BIS)
- Keywords
- Pediatric anesthesia, Intraoperative care, Intraoperative neurophysiological monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral index (BIS)Device
- All patient will receive standard monitoring (EKG, Blood pressure, pulse oximetry), and BIS transducer placement at standard frontal area before anesthesia.
- Sedative medication can be given as appropriate.
- Anesthesia induction by inhalation induction with sevoflurane (if intravenous line not presented) or intravenous induction with thiopental 5-6 mg/kg IV
- Other medication including fentanyl 1 mcg/kg IV and cisatracurium 0.1-0.2 mg/kg IV will be given and the patient will be intubated.
- The second BIS will be installed on the bridge of the nose and temporal on the same side as frontal BIS.
- The patient will be maintained with sevoflurane and other anesthetic drugs as appropriate, adjusted per frontal BIS (40-60).
- The frontal BIS and the nasal BIS will be measured until the endotracheal tube is being removed. If the patient has moved until it was impossible to measure the BIS or has any necessity to cancel the BIS measurement. The BIS measurement can be stopped.
| Study group | Role | What they receive |
|---|---|---|
| BIS | Experimental | The patients will receive both standard frontal and nasal BIS monitoring during general anesthesia. Receives: Device: Bispectral index (BIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
bispectral index (BIS) value
BIS is a processed electroencephalogram (range from 0-100), the optimal value of BIS during general anesthesia is 40-60. We aim to define the differences between standard frontal BIS and nasal BIS using Bland-Altman analysis.
Measured: 5 hours
Secondary outcomes (2)
signal quality index (SQI)
SQI (range from 0-100) determines the quality of signal of the primary outcome (BIS). We aim to define the differences of SQI of BIS between standard frontal and nasal positions.
Measured: 5 hours
electromyography (EMG)
EMG (range from 0-100) reports the interference of muscle activity on quality of the primary outcome (BIS). We aim to define the differences of EMG between standard frontal and nasal positions.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start3 May 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BISStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Siriraj Hospital
- Responsible party
- Sponsor
- Investigators
- Taniga Kiatchai, MD., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255236
- Sponsor's protocol ID
- Si 785/2023
- Status last verified
- Dec 2024
- First submitted
- 15 Jan 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nelson P, Nelson JA, Chen AJ, Kofke WA. An alternative position for the BIS-Vista montage in frontal approach neurosurgical cases. J Neurosurg Anesthesiol. 2013 Apr;25(2):135-42. doi: 10.1097/ANA.0b013e31826ca3a0.
PubMed 23456030
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Accuracy of Bispectral Index Monitoring in an Alternative Nasal Position Compared With Standard Frontal Position in Pediatric Patients Under General Anesthesia With Sevoflurane
- ClinicalTrials.gov ID
- NCT06255236
- Acronym / sponsor ID
- Si 785/2023
- Conditions
- BIS
- Keywords
- Pediatric anesthesia, Intraoperative care, Intraoperative neurophysiological monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Siriraj Hospital
- Study start
- 3 May 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 13 Feb 2024 (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.
To compare the accuracy of frontal versus nasal BIS monitoring in pediatric patients under general anesthesia.
Detailed description
Standard position of frontal bispectral index (BIS) may not be available in some operations that frontal area is occupied by surgical field. This prospective cohort study aims to compare the accuracy of the BIS between an alternative position across the nasal area with the standard frontal BIS position in pediatric patients undergoing general anesthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIS | Experimental | Device: Bispectral index (BIS)The patients will receive both standard frontal and nasal BIS monitoring during general anesthesia. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients undergoing general anesthesia
- American Society of Anesthesiologists physical status 1-3
Key exclusion criteria (6 listed)
- Patients with neurological diseases
- Patients who are using anticonvulsant drugs
- Patients who is expected to be intubated and return to the pediatric intensive care unit
- Patients undergoing head and face surgery
- Patients undergoing surgery in the prone position
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)* All patient will receive standard monitoring (EKG, Blood pressure, pulse oximetry), and BIS transducer placement at standard frontal area before anesthesia. * Sedative medication can be given as appropriate. * Anesthesia induction by inhalation induction with sevoflurane (if intravenous line not presented) or intravenous induction with thiopental 5-6 mg/kg IV * Other medication including fentanyl 1 mcg/kg IV and cisatracurium 0.1-0.2 mg/kg IV will be given and the patient will be intubated. * The second BIS will be installed on the bridge of the nose and temporal on the same side as frontal BIS. * The patient will be maintained with sevoflurane and other anesthetic drugs as appropriate, adjusted per frontal BIS (40-60). * The frontal BIS and the nasal BIS will be measured until the endotracheal tube is being removed. If the patient has moved until it was impossible to measure the BIS or has any necessity to cancel the BIS measurement. The BIS measurement can be stopped. | Device | BIS |
Primary outcome
bispectral index (BIS) value
Time frame: 5 hours
BIS is a processed electroencephalogram (range from 0-100), the optimal value of BIS during general anesthesia is 40-60. We aim to define the differences between standard frontal BIS and nasal BIS using Bland-Altman analysis.
2 secondary outcomes
signal quality index (SQI)
Time frame: 5 hours
electromyography (EMG)
Time frame: 5 hours
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 17 Dec 2024.
- Background: PubMed 23456030Nelson P, Nelson JA, Chen AJ, Kofke WA. An alternative position for the BIS-Vista montage in frontal approach neurosurgical cases. J Neurosurg Anesthesiol. 2013 Apr;25(2):135-42. doi: 10.1097/ANA.0b013e31826ca3a0.
- Individual participant dataSharing planned: No
Related trials for BIS
Recruiting
The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
Depth of Anesthesia Monitoring, BIS-EEG
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
RecruitingPhase 1/2
An AAV Gene Therapy Trial of AFTX-201 in Adults With BAG3-Associated Dilated Cardiomyopathy (DCM)
Dilated Cardiomyopathy (DCM), BAG3 Mutation Associated Dilated Cardiomyopathy
RecruitingObservational study
Observational Study of Natural History of BAG3 Gene Mutation-Associated Dilated Cardiomyopathy in Chinese Adults
Dilated Cardiomyopathy
RecruitingObservational study
NIRS and BIS Monitoring During Cerebral Aneurysm Coiling
Cerebral Aneurysm
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.
Taniga Kiatchai, MD. principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bispectral index (BIS) in people with BIS, run by Mahidol University at 1 site in Thailand.
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 6 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 17 Dec 2024. 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 Thailand. 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?
bispectral index (BIS) value (time frame: 5 hours). 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 NCT06255236, which also lists 1 linked publication.
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 17 Dec 2024.