drugset / Trial / NCT07568873

Melatonin vs Metoprolol or Dexmedetomidine to Improve Surgical Field in FESS

NCT07568873

Completed 28 enrolled Zagazig University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This randomized controlled study at Zagazig University Hospitals will include 112 patients undergoing elective functional endoscopic sinus surgery, allocated into four groups (Melatonin, Metoprolol, Dexmedetomidine, Control). Preoperatively, patients will provide consent, undergo history, clinical and airway assessment, baseline vitals, laboratory tests, and serum cortisol and glucose measurement. Intraoperatively, standard monitoring will be applied, and study drugs administered according to group. Anesthesia will be induced with propofol, fentanyl, and atracurium, and maintained with isoflurane and controlled ventilation. Hemodynamics will be continuously monitored, and surgical field graded using ACS score, with interventions for hypotension, bradycardia, or tachycardia as needed. Postoperatively, emergence agitation, hemodynamics, and drug-related side effects will be recorded, and surgeon satisfaction assessed with a 5-point Likert scale.

Timeline

Start
2024-01-25
Primary completion
2024-12-01
Completion
2025-01-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 1 ug/kg Intravenous
Subject Melatonin Small molecule 6 mg Oral
Subject Metoprolol Other / unclassified 4 mg Intravenous

Indications

No indication recorded.