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Completed

NCT Number: NCT06255236

Pediatric Frontal and Nasal Bispectral Index

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

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Key information

Conditions

BIS

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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

  1. signal quality index (SQI)

    Time frame: 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.

  2. electromyography (EMG)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • Siriraj Hospital

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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