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A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation

NCT04928391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Cleft Palate

Interventions

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Omar Soliman · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-20
Primary Completion
2026-03-05
Completion
2026-03-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04928391 on ClinicalTrials.gov