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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2022-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Mirtazapine group (Group I) (n=55)

Group Type ACTIVE_COMPARATOR

Mirtazapine

Intervention Type DRUG

Every patient will be given mirtazapine 30 mg tablet

Melatonin group (Group II) (n=55)

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

Every patient will be given melatonin 5 mg tablet

Placebo group (Group III) (n=55)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Every patient will be given a matching placebo tablet

Interventions

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Mirtazapine

Every patient will be given mirtazapine 30 mg tablet

Intervention Type DRUG

Melatonin

Every patient will be given melatonin 5 mg tablet

Intervention Type DRUG

Placebo

Every patient will be given a matching placebo tablet

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No