Melatonin vs Metoprolol or Dexmedetomidine to Improve Surgical Field in FESS

Zagazig University28 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Stress Response of Endotracheal Intubation and Surgical Field Clarity in FESS

Interventions

MelatoninDRUG

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

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

DexmedetomidineDRUG

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.

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Medicine, Zagazig Univeristy

Zagazig, Sharqia Province, Egypt

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 2 hours

Data from ClinicalTrials.gov

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