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

NCT06225037 | Completed

• 1 other identifier: 2023/2337
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

EEG-guided sedation

Outcome Measures

Primary Outcomes (1)

• Time to wake up

  Our primary hypothesis is that in children aged 6-16, personalised EEG-guided anaesthesia care using the Sedline, (based on the raw EEG, density spectral array, in addition to the patient state index (PSI)), will result in faster wake up (defined as time from end of procedure to time of first eye opening) after propofol sedation for OGD and colonoscopy by 8 minutes

  Through study completion, approximately 6 months

Secondary Outcomes (6)

• Time to discharge

  Through study completion, approximately 6 months

• Propofol dosage

  Through study completion, approximately 6 months

• Intraoperative adverse events

  Through study completion, approximately 6 months

• Undesirable movement

  Through study completion, approximately 6 months

• Emergence delirium

  Through study completion, approximately 6 months

Study Arms (2)

Group 1: EEG Monitoring

EXPERIMENTAL

EEG sensor placed with the EEG monitored.

Device: Sedline EEG monitoring

Group 2: Standard Care

ACTIVE COMPARATOR

EEG sensor placed with the output concealed.

Device: Sedline EEG with output concealed

Interventions

Sedline EEG monitoring DEVICE

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.

Group 1: EEG Monitoring

Sedline EEG with output concealed DEVICE

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

Group 2: Standard Care

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Paediatric patients aged 6-16 who are undergoing oesophagogastroduodenoscopy and colonoscopy in KKH under propofol sedation
• Parent/guardian must consent to participation in the study and patient must assent to participation in the study

You may not qualify if:

• Patients with neurological diseases including seizure disorders
• Patients with developmental delay or genetic syndromes
• Patients with craniofacial deformities where it is not possible to place the EEG sensors
• Patients with severe eczema or skin allergy or atopy
• Patients who require sedative premedication or who require inhalational induction prior to initiation of propofol sedation

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (9)

• Patino M, Glynn S, Soberano M, Putnam P, Hossain MM, Hoffmann C, Samuels P, Kibelbek MJ, Gunter J. Comparison of different anesthesia techniques during esophagogastroduedenoscopy in children: a randomized trial. Paediatr Anaesth. 2015 Oct;25(10):1013-9. doi: 10.1111/pan.12717. Epub 2015 Jul 17.

  PMID: 26184697 BACKGROUND

• Bong CL, Balanza GA, Khoo CE, Tan JS, Desel T, Purdon PL. A Narrative Review Illustrating the Clinical Utility of Electroencephalogram-Guided Anesthesia Care in Children. Anesth Analg. 2023 Jul 1;137(1):108-123. doi: 10.1213/ANE.0000000000006267. Epub 2023 Jun 16.

  PMID: 36729437 BACKGROUND

• Bloom J, Wyler D, Torjman MC, Trinh T, Li L, Mehta A, Fitchett E, Kastenberg D, Mahla M, Romo V. High Incidence of Burst Suppression during Propofol Sedation for Outpatient Colonoscopy: Lessons Learned from Neuromonitoring. Anesthesiol Res Pract. 2020 Jun 19;2020:7246570. doi: 10.1155/2020/7246570. eCollection 2020.

  PMID: 32636880 BACKGROUND

• Fritz BA, Kalarickal PL, Maybrier HR, Muench MR, Dearth D, Chen Y, Escallier KE, Ben Abdallah A, Lin N, Avidan MS. Intraoperative Electroencephalogram Suppression Predicts Postoperative Delirium. Anesth Analg. 2016 Jan;122(1):234-42. doi: 10.1213/ANE.0000000000000989.

  PMID: 26418126 BACKGROUND

• Yuan I, Landis WP, Topjian AA, Abend NS, Lang SS, Huh JW, Kirschen MP, Mensinger JL, Zhang B, Kurth CD. Prevalence of Isoelectric Electroencephalography Events in Infants and Young Children Undergoing General Anesthesia. Anesth Analg. 2020 Feb;130(2):462-471. doi: 10.1213/ANE.0000000000004221.

  PMID: 31107263 BACKGROUND

• Soehle M, Kuech M, Grube M, Wirz S, Kreuer S, Hoeft A, Bruhn J, Ellerkmann RK. Patient state index vs bispectral index as measures of the electroencephalographic effects of propofol. Br J Anaesth. 2010 Aug;105(2):172-8. doi: 10.1093/bja/aeq155. Epub 2010 Jun 29.

  PMID: 20587537 BACKGROUND

• Weber F, Walhout LC, Escher JC. The impact of Narcotrend EEG-guided propofol administration on the speed of recovery from pediatric procedural sedation-A randomized controlled trial. Paediatr Anaesth. 2018 May;28(5):443-449. doi: 10.1111/pan.13365. Epub 2018 Mar 25.

  PMID: 29575232 BACKGROUND

• Weber F, Pohl F, Hollnberger H, Taeger K. Impact of the Narcotrend Index on propofol consumption and emergence times during total intravenous anaesthesia with propofol and remifentanil in children: a clinical utility study. Eur J Anaesthesiol. 2005 Oct;22(10):741-7. doi: 10.1017/s0265021505001237.

  PMID: 16211731 BACKGROUND

• Long MHY, Lim EHL, Balanza GA, Allen JC Jr, Purdon PL, Bong CL. Sevoflurane requirements during electroencephalogram (EEG)-guided vs standard anesthesia Care in Children: A randomized controlled trial. J Clin Anesth. 2022 Oct;81:110913. doi: 10.1016/j.jclinane.2022.110913. Epub 2022 Jun 27.

  PMID: 35772250 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Choon Looi Bong

  Singhealth Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 25, 2024
• Study Start: December 15, 2023
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: April 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)