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EEG-guided Propofol Sedation Versus Standard Care for Oesophagogastroduodenoscopy and Colonoscopy in Children

NCT06225037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-18

No results posted yet for this study

Summary

The goal of this clinical trial is to compare electroencephalogram (EEG) guided propofol sedation versus standard care in paediatric patients aged 6-16 undergoing oesophagogastroduodenoscopy and colonoscopy. The main questions it aims to answer are whether EEG guided propofol sedation will result in:

* faster wake up time
* reduced time to discharge
* reduced cumulative propofol dosage
* lower incidence of intraoperative adverse events
* no difference in intraoperative undesirable movement
* lower incidence and severity of emergence delirium
* lower intraoperative depth of sedation Participants will wear an EEG sensor (Sedline) prior to undergoing propofol sedation until they wake up post procedure.

Conditions

  • Anesthesia
  • Anesthesia; Adverse Effect
  • Anesthesia Emergence Delirium
  • Sedation Complication
  • Sedative Adverse Reaction

Interventions

DEVICE

Sedline EEG monitoring

Propofol titrated according to the raw EEG and spectrogram, aiming to maintain sedation (alpha oscillations +/- slow oscillations) and preventing burst suppression, keeping the PSI greater than 25 where possible.

DEVICE

Sedline EEG with output concealed

Clinician will be blinded to the sedline output but data will be collected for analysis (Sedline output will only be analysed at data analysis)

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Choon Looi Bong · Singhealth Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2024-10-25
Completion
2024-10-25

Countries

  • Singapore

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 NCT06225037 on ClinicalTrials.gov