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

Study Overview
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Brief Summary
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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.

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

Conditions
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Agitation

Intervention / Treatment
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* Drug: Mirtazapine
* Drug: Melatonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients according to American Society of Anesthesiologists physical status classification (ASA) I or II. Patients according to Mallampati classification I or II. Patients accepting the study and consenting. Undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery. Body mass index(BMI)<30 Exclusion Criteria: Patient's refusal. Known allergy to any of the study medications. History of obstructive sleep apnea. History of psychiatric illness or intake of antipsychotics. History of liver impairment. Pregnancy. History of uncontrolled hypertension. History of renal disease. Body mass index (BMI) ≥30 kg/m2. Contraceptive drugs.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mirtazapine group (Group I) (n=55)<br> | Drug: Mirtazapine<br>* Every patient will be given mirtazapine 30 mg tablet<br>|
| Active Comparator: Melatonin group (Group II) (n=55)<br> | Drug: Melatonin<br>* Every patient will be given melatonin 5 mg tablet<br>|
| Placebo Comparator: Placebo group (Group III) (n=55)<br> | Drug: Placebo<br>* Every patient will be given a matching placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of patients with the Riker sedation-agitation score ≥5 | Total number of patients with the Riker sedation-agitation score ≥5 | 24 hours postoperatively |