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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04908605

Enrollment

165

Registered

2021-06-01

Start date

2021-06-15

Completion date

2022-03-31

Last updated

2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation

Brief 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.

Interventions

DRUGMirtazapine

Every patient will be given mirtazapine 30 mg tablet

DRUGMelatonin

Every patient will be given melatonin 5 mg tablet

DRUGPlacebo

Every patient will be given a matching placebo tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

21 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Total number of patients with the Riker sedation-agitation score ≥5	24 hours postoperatively	Total number of patients with the Riker sedation-agitation score ≥5

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026