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A Single Bolus of Dexmedetomidine Versus Nalbuphine in Postoperative Agitation

Cleft Palate Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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 a single dose of 0.1 mg/kg IV nalbuphine (Group N) or same volume of saline placebo (Group C). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04928391
Study type Interventional
Source Assiut University
Contact Omar Soliman, MD
Phone 01101266040
Email omarmakram347@yahoo.com
Status Recruiting
Phase Phase 3
Start date June 20, 2021
Completion date May 20, 2025
View Details
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