Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Mirtazapine group (Group I) (n=55)
|
Drug: Mirtazapine
Every patient will be given mirtazapine 30 mg tablet
|
Active Comparator: Melatonin group (Group II) (n=55)
|
Drug: Melatonin
Every patient will be given melatonin 5 mg tablet
|
Placebo Comparator: Placebo group (Group III) (n=55)
|
Drug: Placebo
Every patient will be given a matching placebo tablet
|
Outcome Measures
Primary Outcome Measures
- Total number of patients with the Riker sedation-agitation score ≥5 [24 hours postoperatively]
Total number of patients with the Riker sedation-agitation score ≥5
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients according to American Society of Anesthesiologists physical status classification (ASA) I or II.
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Patients according to Mallampati classification I or II.
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Patients accepting the study and consenting.
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Undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery.
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Body mass index(BMI)<30
Exclusion Criteria:
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Patient's refusal.
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Known allergy to any of the study medications.
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History of obstructive sleep apnea.
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History of psychiatric illness or intake of antipsychotics.
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History of liver impairment.
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Pregnancy.
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History of uncontrolled hypertension.
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History of renal disease.
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Body mass index (BMI) ≥30 kg/m2.
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Contraceptive drugs.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ain-Shams University Hospitals | Cairo | Egypt |
Sponsors and Collaborators
- Ain Shams University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FMASU MS251 /202l