Melatonin vs Metoprolol or Dexmedetomidine to Improve Surgical Field in FESS

NCT07568873 | Completed

• 1 other identifier: Zagazig-IRB-------------------
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Control group

PLACEBO COMPARATOR

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)

group ML

OTHER

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

group MP

OTHER

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)

dexmedetomidine group

OTHER

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

Interventions

Melatonin DRUG

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

Also known as: group ML

group ML

Metoprolol (MET) DRUG

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

group MP

Dexmedetomidine DRUG

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.

dexmedetomidine group

Placebo capsules (vitamin d) DRUG

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.

Also known as: Placebo comparator (Control group)

Control group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine, Zagazig Univeristy

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Interventions

Melatonin; Metoprolol; Dexmedetomidine; Vitamin D; Control Groups

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: May 6, 2026
• Study Start: January 25, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 15, 2025
• Last Updated: May 6, 2026

Record last verified: 2024-01

Locations

EG (1)