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.

Treatment Details

Interventions

• Melatonin (Hormone Therapy)
• Mirtazapine (Antidepressant)
• Placebo (Behavioural Intervention)

Participant Groups

Group I: Mirtazapine group (Group I) (n=55) Active Control 1 Intervention

Group II: Melatonin group (Group II) (n=55) Active Control 1 Intervention

Group III: Placebo group (Group III) (n=55) Placebo Group 1 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

Research Locations Nearby Select from list below to view details:

Who Is Running the Clinical Trial?

Ain Shams University Lead Sponsor

References