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

Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908605
• Other study ID #: FMASU MS251 /202l
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients according to American Society of Anesthesiologists physical status classification (ASA) I or II.

2. Patients according to Mallampati classification I or II.

3. Patients accepting the study and consenting.

4. Undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery.

5. Body mass index(BMI)<30

Exclusion Criteria:

1. Patient's refusal.

2. Known allergy to any of the study medications.

3. History of obstructive sleep apnea.

4. History of psychiatric illness or intake of antipsychotics.

5. History of liver impairment.

6. Pregnancy.

7. History of uncontrolled hypertension.

8. History of renal disease.

9. Body mass index (BMI) =30 kg/m2.

10. Contraceptive drugs.

Related Conditions & MeSH terms

• Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Mirtazapine
Every patient will be given mirtazapine 30 mg tablet
• Melatonin
Every patient will be given melatonin 5 mg tablet
• Placebo
Every patient will be given a matching placebo tablet

Locations

Country	Name	City	State
Egypt	Ain-Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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