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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04908605
Collaborator
(none)
165
1
3
9.5
17.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
Actual Study Start Date :
Jun 15, 2021
Actual Primary Completion Date :
Mar 31, 2022
Actual Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Mirtazapine group (Group I) (n=55)

Drug: Mirtazapine
Every patient will be given mirtazapine 30 mg tablet

Active Comparator: Melatonin group (Group II) (n=55)

Drug: Melatonin
Every patient will be given melatonin 5 mg tablet

Placebo Comparator: Placebo group (Group III) (n=55)

Drug: Placebo
Every patient will be given a matching placebo tablet

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain-Shams University Hospitals Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr.Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University
ClinicalTrials.gov Identifier:
NCT04908605
Other Study ID Numbers:
  • FMASU MS251 /202l
First Posted:
Jun 1, 2021
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022