Skip to main content
OpenTrials
Completed

NCT Number: NCT04908605

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Agitation Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain-Shams University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Undergoing general anesthesia for elective nasal surgery in which nasal packing on each side was used until 24 h after surgery.
  • Body mass index(BMI)<30

Exclusion criteria

  • Patient's refusal.
  • Known allergy to any of the study medications.
  • History of obstructive sleep apnea.
  • History of psychiatric illness or intake of antipsychotics.
  • History of liver impairment.
  • Pregnancy.
  • History of uncontrolled hypertension.
  • History of renal disease.
  • Body mass index (BMI) ≥30 kg/m2.
  • Contraceptive drugs.

Treatment and study plan

mirtazapine

Drug

Every patient will be given mirtazapine 30 mg tablet

Melatonin

Drug

Every patient will be given melatonin 5 mg tablet

Placebo

Drug

Every patient will be given a matching placebo tablet

Primary outcomes

  1. Total number of patients with the Riker sedation-agitation score ≥5

    Time frame: 24 hours postoperatively

    Total number of patients with the Riker sedation-agitation score ≥5

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2021
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.