NCT04908605

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Agitation

Interventions

Type	Name	Description
DRUG	Mirtazapine	Every patient will be given mirtazapine 30 mg tablet
DRUG	Melatonin	Every patient will be given melatonin 5 mg tablet
DRUG	Placebo	Every patient will be given a matching placebo tablet

Timeline

• Start date: 2021-06-15
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-06-01
• Last updated: 2022-04-15

Locations

1 site across 1 country: Egypt