Intranasal dexmedetomidine to reduce emergence agitation after children's strabismus surgery
Effect of Two Different Doses of Intranasal Dexmedetomidine on the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery , A Randomized Clinical Trial
NA · Alexandria University · NCT07523438
This trial will test whether giving children aged 3–6 undergoing strabismus surgery intranasal dexmedetomidine at 3 mcg/kg reduces emergence agitation compared with 2 mcg/kg.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 3 Years to 6 Years |
| Sex | All |
| Sponsor | Alexandria University (other) |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT07523438 on ClinicalTrials.gov |
What this trial studies
Preschool children (ages 3–6) undergoing strabismus surgery receive intranasal dexmedetomidine at one of two doses (3 mcg/kg or 2 mcg/kg) before general anesthesia. Participants are assigned to a high-dose or low-dose group and are monitored during recovery for signs of emergence agitation, recovery time, and adverse events. The study compares the incidence and severity of emergence delirium in the postanesthesia care unit between the two dose groups. Safety outcomes include monitoring for oversedation, hemodynamic effects, and nasal discomfort.
Who should consider this trial
Good fit: Ideal candidates are otherwise healthy children aged 3–6 years (ASA I–II) scheduled for strabismus surgery who are not on sedative medications and have no allergy to dexmedetomidine or neurologic/psychiatric disorders.
Not a fit: Children older than 6, those with neurologic or psychiatric disease, BMI over 20 kg/m2, on sedative medications, or allergic to dexmedetomidine are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, a higher intranasal dose could meaningfully reduce post-anesthesia agitation and its complications in young children after strabismus surgery.
How similar studies have performed: Previous pediatric studies have shown intranasal dexmedetomidine can reduce emergence agitation and provide sedation, but the optimal intranasal dose is not yet agreed upon.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 3-6 years, both sexes * ASA physical status class I , II. Exclusion Criteria: * history of neurological and psychiatric disease * body mass index \> 20 kg m-2 * allergy to dexmedetomidine * patients on medical treatment which has any sedative effect * mentally retarded children
Where this trial is running
Alexandria
- Alexandria University — Alexandria, Egypt (RECRUITING)
Study contacts
- Principal investigator: sarah m elgamal, MD — Alexandria University
- Study coordinator: sarah m elgamal, MD
- Email: sarahelgamal1990@yahoo.com
- Phone: 01005496440
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.
Conditions: Dexmedetomidine, Emergence Agitation, emergence agitation, strabismus surgery