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

Primary Purpose

Agitation

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Mirtazapine
Melatonin
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ain-Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Mirtazapine group (Group I) (n=55)

Melatonin group (Group II) (n=55)

Placebo group (Group III) (n=55)

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 27, 2021
Last Updated
April 13, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04908605
Brief Title
Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
Official Title
Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirtazapine group (Group I) (n=55)
Arm Type
Active Comparator
Arm Title
Melatonin group (Group II) (n=55)
Arm Type
Active Comparator
Arm Title
Placebo group (Group III) (n=55)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Intervention Description
Every patient will be given mirtazapine 30 mg tablet
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
Every patient will be given melatonin 5 mg tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Every patient will be given a matching placebo tablet
Primary Outcome Measure Information:
Title
Total number of patients with the Riker sedation-agitation score ≥5
Description
Total number of patients with the Riker sedation-agitation score ≥5
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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