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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Agitation

Treatments: Drug: Placebo; Drug: Mirtazapine; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT04908605

FMASU MS251 /202l

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 3 patient groups, including a placebo group

Mirtazapine group (Group I) (n=55)

Active Comparator group

Treatment:

Drug: Mirtazapine

Melatonin group (Group II) (n=55)

Active Comparator group

Treatment:

Drug: Melatonin

Placebo group (Group III) (n=55)

Placebo Comparator group

Treatment:

Drug: Placebo