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Pediatric Frontal and Nasal Bispectral Index

NCT06255236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-17

No results posted yet for this study

Summary

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

Conditions

  • BIS

Interventions

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.

Sponsors & Collaborators

  • Siriraj Hospital

    collaborator OTHER

  • Mahidol University

    lead OTHER

Principal Investigators

  • Taniga Kiatchai, MD. · Siriraj Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-03
Primary Completion
2024-11-15
Completion
2024-11-15
FDA Device
Yes

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06255236 on ClinicalTrials.gov