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Pediatric Frontal and Nasal Bispectral Index

M

Mahidol University

Status

Completed

Conditions

BIS

Treatments

Device: Bispectral index (BIS)

Study type

Interventional

Funder types

Other

Identifiers

NCT06255236
Si 785/2023

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

BIS
Experimental group
Description:
The patients will receive both standard frontal and nasal BIS monitoring during general anesthesia.
Treatment:
Device: Bispectral index (BIS)

Trial contacts and locations

1

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Central trial contact

Taniga Kiatchai, MD.; Pakjira Sombatthaveekul, MD.

Data sourced from clinicaltrials.gov

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