---
title: Pediatric Frontal and Nasal Bispectral Index
nct_id: NCT06255236
overall_status: COMPLETED
phase: NA
sponsor: Mahidol University
study_type: INTERVENTIONAL
primary_condition: BIS
countries: Thailand
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06255236.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06255236"
ct_last_update_post_date: 2024-12-17
last_seen_at: "2026-05-12T07:20:55.484Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Pediatric Frontal and Nasal Bispectral Index

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

**NCT ID:** [NCT06255236](https://clinicaltrials.gov/study/NCT06255236)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Mahidol University
- **Collaborators:** Siriraj Hospital
- **Conditions:** BIS
- **Start Date:** 2024-05-03
- **Completion Date:** 2024-11-15
- **CT.gov Last Update:** 2024-12-17

## 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.

## Eligibility

- **Minimum age:** 4 Years
- **Maximum age:** 12 Years
- **Sex:** ALL
- **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
```

## Arms

- **BIS** (EXPERIMENTAL) — The patients will receive both standard frontal and nasal BIS monitoring during general anesthesia.

## 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.

## Primary Outcomes

- **bispectral index (BIS) value** _(time frame: 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 Outcomes

- **signal quality index (SQI)** _(time frame: 5 hours)_
- **electromyography (EMG)** _(time frame: 5 hours)_

## Locations (1)

- Siriraj Hospital, Bangkok Noi, Bangkok, Thailand

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.siriraj hospital|bangkok noi|bangkok|thailand` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06255236*  
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