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

To compare the accuracy of frontal versus nasal BIS monitoring in pediatric patients under general anesthesia.

Study Overview

• Status: Completed
• Conditions: BIS
• Intervention / Treatment: Device: Bispectral index (BIS)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BIS; The patients will receive both standard frontal and nasal BIS monitoring during general anesthesia.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	5 hours

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: Siriraj Hospital
• Investigators: Principal Investigator: Taniga Kiatchai, MD., Siriraj Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Intraoperative care; Pediatric anesthesia; Intraoperative neurophysiological monitoring
• Other Study ID Numbers: Si 785/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes