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Pediatric Frontal and Nasal Bispectral Index

An Accuracy of Bispectral Index Monitoring in an Alternative Nasal Position Compared With Standard Frontal Position in Pediatric Patients Under General Anesthesia With Sevoflurane

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06255236
Enrollment
40
Registered
2024-02-13
Start date
2024-05-03
Completion date
2024-11-15
Last updated
2024-12-17

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

Conditions

BIS

Keywords

Pediatric anesthesia, Intraoperative care, Intraoperative neurophysiological monitoring

Brief summary

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.

Interventions

* 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.

Sponsors

Siriraj Hospital
CollaboratorOTHER
Mahidol University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Pediatric patients undergoing general anesthesia * American Society of Anesthesiologists physical status 1-3

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
bispectral index (BIS) value5 hoursBIS 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.

Secondary

MeasureTime frameDescription
signal quality index (SQI)5 hoursSQI (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.
electromyography (EMG)5 hoursEMG (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.

Countries

Thailand

Outcome results

None listed

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