Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
1 other identifier
interventional
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2021
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedStudy Start
First participant enrolled
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedApril 15, 2022
April 1, 2022
10 months
May 27, 2021
April 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Total number of patients with the Riker sedation-agitation score ≥5
Total number of patients with the Riker sedation-agitation score ≥5
24 hours postoperatively
Study Arms (3)
Mirtazapine group (Group I) (n=55)
ACTIVE COMPARATORMelatonin group (Group II) (n=55)
ACTIVE COMPARATORPlacebo group (Group III) (n=55)
PLACEBO COMPARATORInterventions
Every patient will be given mirtazapine 30 mg tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain-Shams University Hospitals
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.
Study Record Dates
First Submitted
May 27, 2021
First Posted
June 1, 2021
Study Start
June 15, 2021
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
April 15, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share