RecruitingPhase 3NCT04928391

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


Sponsor

Assiut University

Enrollment

60 participants

Start Date

Jun 20, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 7 Years

Inclusion Criteria2

  • Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
  • Elective cleft palate repair ± cleft lip surgery under general anesthesia.

Exclusion Criteria7

  • Ventriculo-peritoneal shunt
  • Suspected meningitis
  • Congenital hydrocephalus
  • Clinical signs of suspected increased intracranial pressure
  • On treatment for seizures or metabolic diseases
  • Children with developmental delay
  • Hypersensitivity to dexmedetomidine or nalbuphine

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Interventions

DRUGDexmedetomidine

A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery

OTHER0.9% saline

Same volume of saline placebo IV at the end of surgery


Locations(2)

Omar Soliman

Asyut, Assuit, Egypt

Assiut university hospital

Asyut, Egypt

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NCT04928391


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