Reducing emergence agitation in children after strabismus surgery
The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial
This study tests if using a medication called sugammadex can help reduce confusion and agitation in young children after they have strabismus surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 4 Years to 7 Years |
| Sex | All |
| Sponsor | Konkuk University Medical Center Academic / other |
| Locations | 1 site (Seoul, Seoul-T'ǔkpyǒlshi) |
| Trial ID | NCT06035757 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether the use of sugammadex, a neuromuscular blockade reversal agent, can decrease the incidence of emergence agitation in pediatric patients undergoing strabismus surgery. The study compares sugammadex to neostigmine in children aged 4-7, assessing their recovery using the Pediatric Anesthesia Emergence Delirium (PAED) Scale. Emergence agitation is a common postoperative complication that can be influenced by factors such as anxiety and residual neuromuscular blockade. By evaluating these factors, the trial aims to improve postoperative outcomes for young patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-7 scheduled for elective strabismus surgery with an ASA classification of 1-3.
Not a fit: Patients with ASA classification 3 or higher, impaired liver or kidney function, neuromuscular disorders, or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced rates of emergence agitation in children after surgery, enhancing their recovery experience.
How similar studies have performed: Previous studies have indicated that managing neuromuscular blockade can influence emergence agitation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled elective strabismus surgery aged 4-7 with American Society of Anesthesiologists (ASA) classification 1-3. Exclusion Criteria: * ASA classification 3 or more * impaired liver function * impaired kidney function * myasthenia gravis or other neuromuscular disorders * history of drug allergy * cardiovascular disease or arrhythmia
Where this trial is running
Seoul, Seoul-T'ǔkpyǒlshi
- Konkuk University Medical Center — Seoul, Seoul-T'ǔkpyǒlshi, South Korea (Recruiting)
Study contacts
- Principal investigator: Yea-Ji Lee, M.D Ph. D — Konkuk University Medical Center
- Study coordinator: Yea-Ji Lee, M.D Ph. D
- Email: ladydaisy82@naver.com
- Phone: +82-2-2030-5450
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.