Oral Melatonin Versus Intravenous Metoprolol or Dexmedetomidine for Attenuation of Stress Response to Endotracheal Intubation and Optimizing Surgical Field in Functional Endoscopic Sinus Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Assessment of change in the mean arterial pressure measured in mmHg.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient acceptance.
- •Age: 21-60 years old.
- •Body mass index (BMI): 18-30 kg/m
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Placebo capsules (vitamin d) (Drug)
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.
Intervention: Melatonin (Drug)
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.
Intervention: Metoprolol (MET) (Drug)
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.
Intervention: Dexmedetomidine (Drug)
Outcomes
Primary Outcomes
Assessment of change in the mean arterial pressure measured in mmHg.
Time Frame: 2 hours
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
Assessment of heart rate measured in beats/minute
Time Frame: 2 hours
Assessment of heart rate measured in beats/minute to assess surgical field by ACS score in FES
Secondary Outcomes
No secondary outcomes reported