Melatonin vs Metoprolol or Dexmedetomidine to Improve Surgical Field in FESS

Oral Melatonin Versus Intravenous Metoprolol or Dexmedetomidine for Attenuation of Stress Response to Endotracheal Intubation and Optimizing Surgical Field in Functional Endoscopic Sinus Surgery

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.

Study Overview

• Status: Completed
• Conditions: Stress Response of Endotracheal Intubation and Surgical Field Clarity in FESS
• Intervention / Treatment: Drug: Placebo capsules (vitamin d); Drug: Melatonin; Drug: Metoprolol (MET); Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sharqia Province
    • Zagazig, Sharqia Province, Egypt, 44519
      • Faculty of Medicine, Zagazig Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient acceptance.
2. Age: 21-60 years old.
3. Body mass index (BMI): 18-30 kg/m2. 8
4. Sex: both sexes (male and female).
5. Physical status: American Society of Anesthesiologists (ASA) physical status I and II.
6. Type of operation: elective functioning endoscopic sinus surgery.
7. Duration of surgery: average 2 hours.

Exclusion Criteria:

1. Hypertension and those on beta blockers and calcium channel blockers.
2. Diabetes mellitus and bronchial asthma.
3. Cardiac arrhythmias, atrio-ventricular conduction block, pulse less than 60 beats/min systolic blood pressure less than 100 mm hg.
4. Patients with anticipated difficult intubation (Mallampati score III and IV).
5. Psychiatric illness, intake of antipsychotics, sedatives, anxiolytics and antiepileptic drug.
6. The pregnant and lactating females.
7. Allergy to one of the used drugs.
8. Patient with coagulation disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; receive 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.	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.; Other Names: Placebo comparator (Control group)
Other: group ML; will receive two 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: 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; Other Names: group ML
Other: group MP; will receive two placebo capsules (vitamin D) 60 minutes before surgery, 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 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
Other: dexmedetomidine group; will receive two placebo capsules (vitamin D) 60 minutes before surgery, 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change in the mean arterial pressure measured in mmHg.	surgical field clarity depends on hemodynamic changes as it becomes more clear when heart rate and mean arterial pressure become lower within the safe range	2 hours
Assessment of heart rate measured in beats/minute	Assessment of heart rate measured in beats/minute to assess surgical field by ACS score in FES	2 hours

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Azoles; Polycyclic Compounds; Imidazoles; Amines; Indoles; Steroids; Fused-Ring Compounds; Alcohols; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Propanols; Tryptamines; Secosteroids; Dexmedetomidine; Vitamin D; Metoprolol; Melatonin; Control Groups
• Other Study ID Numbers: Zagazig-IRB-------------------

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No