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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Page 1 of 1 (1 locations)

1

Ain-Shams University Hospitals

Cairo, Egypt