Pediatric Frontal and Nasal Bispectral Index

NCT06255236 | Completed FDA Device

• 1 other identifier: Si 785/2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

BIS

Keywords

Pediatric anesthesia; Intraoperative care; Intraoperative neurophysiological monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• signal quality index (SQI)

  5 hours

• electromyography (EMG)

  5 hours

Study Arms (1)

BIS

EXPERIMENTAL

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

Device: Bispectral index (BIS)

Interventions

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.

BIS

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Siriraj Hospital: collaborator

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

• 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.

  PMID: 23456030 BACKGROUND

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Taniga Kiatchai, MD.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 13, 2024
• Study Start: May 3, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)