drugset / Trial / NCT04908605

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

NCT04908605

Phase 4 Completed 165 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2021-06-15
Primary completion
2022-03-31
Completion
2022-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Melatonin Small molecule 5 mg Oral
Comparator Mirtazapine Other / unclassified 30 mg

Indications

No indication recorded.