Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Ain Shams University
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
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.
+2 more
Participant Groups
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
Melatonin is already approved in European Union, European Union, United States for the following indications:
🇪🇺 Approved in European Union as Circadin for:
- Insomnia in adults aged 55 and over
- Sleep disorders in children with autism spectrum disorder
🇪🇺 Approved in European Union as Slenyto for:
- Insomnia in children and adolescents aged 2-18 with autism spectrum disorder
🇺🇸 Approved in United States as Melatonin for:
- Sleep disorders in children with autism spectrum disorder
- Insomnia in adults
Find a Clinic Near You
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Who Is Running the Clinical Trial?
Ain Shams UniversityLead Sponsor