CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Sedline EEG monitoring +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06225037
NCT06225037N/ACompleted
CompareCT.gov

EEG-guided Propofol Sedation Versus Standard Care for Oesophagogastroduodenoscopy and Colonoscopy in Children: A Randomised Controlled Trial to Improve Sedation Safety and Experience

KK Women's and Children's Hospital·interventional·Posted Jan 25, 2024·Updated Apr 18, 2025

In Brief

A clinical study evaluating Sedline EEG monitoring and Sedline EEG with output concealed for Anesthesia and 4 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia, Anesthesia; Adverse Effect, Anesthesia Emergence Delirium, Sedation Complication, Sedative Adverse Reaction
CountriesSingapore
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJan 25, 2024
Enrollment StartDec 15, 2023
Primary CompletionOct 25, 2024
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 2.4 years ago

Interventions

Sedline EEG monitoringdevice

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.

Sedline EEG with output concealeddevice

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