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

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.

Study Overview

• Status: Completed
• Conditions: Cleft Palate
• Intervention / Treatment: Drug: Dexmedetomidine; Other: 0.9% saline

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Asyut, Egypt
    • Assiut University hospital
  • Assuit
    • Asyut, Assuit, Egypt, Assuit universi
      • Omar Soliman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group D; Dexmedetomidine IV at the end of surgery	Drug: Dexmedetomidine; A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery; Other Names: Precedex
Placebo Comparator: Group C; Same volume of saline placebo IV at the end of surgery	Other: 0.9% saline; Same volume of saline placebo IV at the end of surgery; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Pediatric Anesthesia Emergence Delirium (PAED) score	Emergence delirium (ED) will be measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scores for each of the five listed behaviours (The child makes eye contact with the caregiver/parent, the child's actions are Purposeful, the child is aware of his/her surroundings, the child is restless and the child is inconsolable) are added to achieve a total score (maximum score of 20). A score of ≥ 12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED	1 hour postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC (Face, Legs, Activity, Cry, and Consolability) pain score.	The FLACC is a behavioural pain assessment scale for use for non-verbal or pre-verbal patients unable to self-report their level of pain. Rate your child in each of the five measurement categories, add together, and document total pain score (0 - 10), score 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain.	1 hour postoperative

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Omar Soliman, Assiut University

Publications and helpful links

General Publications

• Milic M, Goranovic T, Knezevic P. Complications of sevoflurane-fentanyl versus midazolam-fentanyl anesthesia in pediatric cleft lip and palate surgery: a randomized comparison study. Int J Oral Maxillofac Surg. 2010 Jan;39(1):5-9. doi: 10.1016/j.ijom.2009.09.007. Epub 2009 Oct 24.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2021
• Primary Completion (Actual): March 5, 2026
• Study Completion (Actual): March 20, 2026

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Mouth Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cleft Palate; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Azoles; Imidazoles; Crystalloid Solutions; Isotonic Solutions; Solutions; Dexmedetomidine; Saline Solution
• Other Study ID Numbers: 17300616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No