NCT04928391

A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation

Optic Nerve Sheath Diameter (ONSD): A New Modality to Assess Postoperative Agitation After a Single Bolus of Dexmedetomidine Versus Normal Saline in Children With Cleft Palate Repair

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 1 Year – 7 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis of this study is to investigate and compare the efficacy between the administrations of single intravenous (IV) dose of dexmedetomidine versus normal saline in preventing immediate postoperative agitation in children undergoing cleft palate repair.

Detailed description

A written informed consent will be taken from the guardian of children.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive the study drug at the end of surgery; a single dose of 0.5 µ/kg IV dexmedetomidine (Group D) or same volume of saline placebo (Group C).

Conditions

• Cleft Palate

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery
OTHER	0.9% saline	Same volume of saline placebo IV at the end of surgery

Timeline

• Start date: 2021-06-20
• Primary completion: 2027-02-05
• Completion: 2027-03-20
• First posted: 2021-06-16
• Last updated: 2026-01-02

Locations

2 sites across 1 country: Egypt