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Melatonin vs Metoprolol or Dexmedetomidine to Improve Surgical Field in FESS

NCT07568873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Stress Response of Endotracheal Intubation and Surgical Field Clarity in FESS

Interventions

DRUG

Melatonin

wo melatonin capsules (3 mg each) 60 minutes before surgery, intravenous normal saline in a 10 ml 11 syringe 5 minutes before induction and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction

DRUG

Metoprolol (MET)

4 mg of intravenous metoprolol diluted to a volume of 10 ml normal saline 5 minutes before induction, and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a

DRUG

Dexmedetomidine

intravenous normal saline in a 10 ml syringe 5 minutes before induction and 1 microgram/Kg of dexmedetomidine diluted to a volume of 50 ml normal saline in a 50 ml syringe over 10 minutes before induction.

DRUG

Placebo capsules (vitamin d)

two placebo capsules (vitamin D) 60 minutes before surgery, intravenous normal saline in a 10 ml syringe 5 minutes before induction and normal saline in a 50 ml syringe (labeled as 200 microgram) will be given over 10 minutes by a rate of 1 microgram /kg before induction.

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07568873 on ClinicalTrials.gov