NCT04908605 is a Phase 4 clinical trial of Mirtazapine in Agitation, sponsored by Ain Shams University.

Who is sponsoring NCT04908605?

NCT04908605 is sponsored by Ain Shams University.

What drugs are being tested in NCT04908605?

Interventions in NCT04908605: Mirtazapine, Melatonin, Placebo.

Is NCT04908605 still recruiting?

NCT04908605 is currently completed. Last updated 15 April 2022.

Last reviewed 2022-04-15 · How we verify

NCT04908605

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

Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine

Completed Phase 4 Last updated 15 April 2022

What this trial tests

Phase 4 trial testing Mirtazapine in Agitation in 165 participants. Completed in 31 March 2022.

Timeline

15 June 2021

Primary endpoint
31 March 2022

31 March 2022

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	165
Start date	15 June 2021
Primary completion	31 March 2022
Estimated completion	31 March 2022
Sites	1 location across Egypt

Drugs / interventions tested

Mirtazapine — full drug profile →
Melatonin (MELATONIN) — full drug profile →
Placebo

Conditions studied

Agitation — all drugs for Agitation →

Sponsor

Ain Shams University

Who can join

Adults 21 to 60, any sex, with Agitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Emergence agitation (EA) is common after nasal surgery under general anesthesia, which can lead to several problems, such as increased risk of injury to the patient or medical staff, pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and unplanned self-extubation. Melatonin is an oral or sublingual medication, most commonly used for insomnia and improving sleep in different conditions for example shift-work disorder and for helping people to establish a day and night cycle especially blind children or adults. Mirtazapine is an antidepressant used in medicine in a pill form, most commonly used for major depressive disorder and other mood disorders, relief of anxiety, panic disorders, insomnia, headache and migraine.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Mirtazapine

Trials testing the same drug.

NCT06684470 — Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodul · EARLY_PHASE1 · recruiting
NCT06323837 — Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treat · Phase 2 · recruiting
NCT04728581 — Improving Sleep After TKA Using Mirtazapine and Quetiapine · NA · not yet recruiting
NCT04446039 — Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea · completed
NCT05452174 — Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP) · Phase 1, PHASE2 · withdrawn

Other recruiting trials for Agitation

Currently open trials in the same condition.

NCT06937229 — A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) · Phase 3 · recruiting
NCT05522647 — Detection of Risk Behaviors: Pilot Observational Study With Bedridden and Agitated Patients. · recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting

Other Ain Shams University trials

Trials by the same sponsor.

NCT07435493 — Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstru · NA · not yet recruiting
NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting
NCT07531030 — Posterior Pericapsular Deep Gluteal Block Combined With Pericapsular Nerve Group and Lateral Femoral Cutaneous Nerve Blo · NA · not yet recruiting
NCT06839027 — Arterial to Central co2gap in Relation to Outcome After Cardiopulmonary Bypass · not yet recruiting
NCT07516535 — DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones · NA · 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 NCT04908605 (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 Ain Shams University
Last refreshed: 15 April 2022

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/NCT04908605.

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