Pediatric Frontal and Nasal Bispectral Index

Not Applicable

Completed

• Conditions: BIS
• Interventions: Device: Bispectral index (BIS)

• Registration Number: NCT06255236
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-13
• Study Start: 2024-05-03
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIS	Bispectral index (BIS)	The patients will receive both standard frontal and nasal BIS monitoring during general anesthesia.

Primary Outcome Measures

Name	Time	Method
bispectral index (BIS) value	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.

Secondary Outcome Measures

Name	Time	Method
signal quality index (SQI)	5 hours	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.
electromyography (EMG)	5 hours	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.

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok Noi, Bangkok, Thailand