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Clinical Trials/NCT06255236
NCT06255236CompletedNot Applicable

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

Mahidol University1 site in 1 country40 target enrollmentStarted: May 3, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
bispectral index (BIS) value

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
4 Years to 12 Years (Child)
Sex
All
Accepts 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 & Interventions

BIS

Experimental

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

Intervention: Bispectral index (BIS) (Device)

Outcomes

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)(5 hours)
  • electromyography (EMG)(5 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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