NCT04928391 is a Phase 3 clinical trial of Dexmedetomidine in Cleft Palate, sponsored by Assiut University.

Who is sponsoring NCT04928391?

NCT04928391 is sponsored by Assiut University.

What drugs are being tested in NCT04928391?

Interventions in NCT04928391: Dexmedetomidine, 0.9% saline.

What condition does NCT04928391 study?

NCT04928391 studies Cleft Palate.

Is NCT04928391 still recruiting?

NCT04928391 is currently recruiting now. Last updated 2 January 2026.

Last reviewed 2026-01-02 · How we verify

NCT04928391

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Single Bolus of Dexmedetomidine Versus Normal Saline in Postoperative Agitation

Recruiting now Phase 3 Last updated 2 January 2026

What this trial tests

Phase 3 trial testing Dexmedetomidine in Cleft Palate in 60 participants. Currently enrolling.

Timeline

20 June 2021

Primary endpoint
5 February 2027

20 March 2027

Quick facts

Lead sponsor	Assiut University
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	20 June 2021
Primary completion	5 February 2027
Estimated completion	20 March 2027
Sites	2 locations across Egypt

Drugs / interventions tested

Dexmedetomidine (dexmedetomidine) — full drug profile →
0.9% saline

Conditions studied

Cleft Palate — all drugs for Cleft Palate →

Sponsor

Assiut University

Who can join

Adults 1 to 7, any sex, with Cleft Palate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Dexmedetomidine

Trials testing the same drug.

NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
NCT07398066 — DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial) · NA · not yet recruiting
NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
NCT07306702 — Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients · Phase 4 · withdrawn
NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting

Other recruiting trials for Cleft Palate

Currently open trials in the same condition.

NCT06962306 — Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery · Phase 4 · recruiting
NCT06856330 — Effect of Furlow Palatoplasty With Buccal Myomucosal Flap on the Speech Development · recruiting
NCT06420336 — QL vs LAI for Palatoplasty · NA · recruiting
NCT05778903 — Maxillary Nerve Blocks in Children - An MRI Study of the Suprazygomatic Approach · NA · recruiting
NCT04928352 — Nebulized Bupivacaine Analgesia for Cleft Palate Repair · Phase 3 · recruiting

Other Assiut University trials

Trials by the same sponsor.

NCT07423312 — Lead Exposure and Multiple Sclerosis · not yet recruiting
NCT07234526 — Usage of Glucose Fluctuations as a Prognostic Marker in Septic Shock Patients · not yet recruiting
NCT07273214 — Knowledge, Attitude and Practice of Third Trimester Pregnant Mothers Towards Self-Medication in Assiut, Egypt · not yet recruiting
NCT07194863 — Efficacy of Essential Phospholipid Versus Betaine HCL/L-Glutamic Acid in MAFLD · not yet recruiting
NCT07053709 — Screening for Hyperuricemia in Patients With Metabolic Associated Fatty Liver Disease (MAFLD) · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04928391 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assiut University
Last refreshed: 2 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04928391.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing