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NCT04103138: EEGPAC
EEG Monitoring Under Anaesthesia in Children: Towards Personalized Anaesthesia Care
NA trial testing Sedline EEG sensor placement in Depth of Anaesthesia in 200 participants. Completed in 31 March 2021.
31 March 2021
Quick facts
| Lead sponsor | KK Women's and Children's Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 200 |
| Start date | 26 September 2019 |
| Primary completion | 31 March 2021 |
| Estimated completion | 31 March 2021 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- Sedline EEG sensor placement
- Sedline EEG monitoring
Conditions studied
- Depth of Anaesthesia — all drugs for Depth of Anaesthesia →
- EEG — all drugs for EEG →
- Anesthesia Emergence Delirium — all drugs for Anesthesia Emergence Delirium →
Sponsor
KK Women's and Children's Hospital
Who can join
Adults 1 to 16, any sex, with Depth of Anaesthesia or EEG. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Electroencephalographic recordings (EEG) present an opportunity to monitor changes in human brain electrical activity during changing states of consciousness during general anesthesia. The investigators aim to determine if EEG-guided anaesthesia using the Masimo Sedline Root monitor will result in different anaesthetic requirements, different anaesthetic depth, and emergence characteristics in children under 16 years of age. 200 children under 16 years undergoing routine general anaesthesia under sevoflurane will be randomized to either EEG monitoring or routine care. We will compare the anaesthetic requirements, the patient state index, number of episodes of burst suppression and the incidence and severity of emergence delrium between the two groups.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04103138
- Europe PMC full search
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Other KK Women's and Children's Hospital trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04103138 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by KK Women's and Children's Hospital
- Last refreshed: 24 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04103138.
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