Status:
COMPLETED
Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine
Lead Sponsor:
Ain Shams University
Conditions:
Agitation
Eligibility:
All Genders
21-60 years
Phase:
PHASE4
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04908605
Start Date
June 15 2021
End Date
March 31 2022
Last Update
April 15 2022
Active Locations (1)
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1
Ain-Shams University Hospitals
Cairo, Egypt