Monitoring brain activity to understand delirium in children after surgery
Perioperative EEG-Monitoring and Emergence Delirium in Children: a Prospective Observational Study
This study is testing how brain activity can help us understand and predict delirium in children under 16 after they have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT04091724 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mechanisms and predictors of emergence delirium in children under 16 years who are scheduled for elective surgery. By utilizing multichannel electroencephalogram (EEG) monitoring, the study will assess neurophysiological states during anesthesia and recovery. The Pediatric Anesthesia Emergence Delirium Scores (PAED Score) will be employed to evaluate the occurrence of emergence delirium in the post-anesthesia care unit. The findings may help clarify the incidence and management strategies for this condition in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 16 years scheduled for elective surgery.
Not a fit: Patients with a history of neurological or psychiatric disease or those with delayed development may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of emergence delirium in children, enhancing their recovery experience.
How similar studies have performed: While the specific approach of using EEG monitoring for this purpose may be novel, similar studies have explored emergence delirium in children, indicating potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. male or female children aged under 16 years 2. planned elective surgery 3. informed consent by parents or legal guardians Exclusion Criteria: 1. history of neurological or psychiatric disease 2. delayed development 3. inability of the parents or legal guardians to speak or read Chinese 4. participation in another prospective interventional clinical study during this study
Where this trial is running
Wuhan, Hubei
- Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Hua Zheng, M.D.
- Email: hzheng@hust.edu.cn
- Phone: 0086-27-83663173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.