Stress Response of Endotracheal Intubation and Surgical Field Clarity in FESS
Conditions
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.
Interventions
DRUGMelatonin
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
DRUGMetoprolol (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
DRUGDexmedetomidine
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.
DRUGPlacebo 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
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of change in the mean arterial pressure measured in mmHg. | 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 | 2 hours | Assessment of heart rate measured in beats/minute to assess surgical field by ACS score in FES |
Countries
Egypt
Outcome results
None listed