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Hormone Therapy

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

Phase 4
Waitlist Available
Research Sponsored by Ain Shams University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours postoperatively
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

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.

Eligible Conditions
  • Agitation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total number of patients with the Riker sedation-agitation score ≥5

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Mirtazapine group (Group I) (n=55)Active Control1 Intervention
Group II: Melatonin group (Group II) (n=55)Active Control1 Intervention
Group III: Placebo group (Group III) (n=55)Placebo Group1 Intervention

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Who is running the clinical trial?

Ain Shams UniversityLead Sponsor
1,473 Previous Clinical Trials
170,232 Total Patients Enrolled
1 Trials studying Agitation
70 Patients Enrolled for Agitation
~37 spots leftby Jan 2026