Oral Melatonin Versus Intravenous Metoprolol or Dexmedetomidine for Attenuation of Stress Response to Endotracheal Intubation and Optimizing Surgical Field in Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Assessment of change in the mean arterial pressure measured in mmHg.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Assessment of change in the mean arterial pressure measured in mmHg.
时间窗: 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
时间窗: 2 hours
Assessment of heart rate measured in beats/minute to assess surgical field by ACS score in FES
次要结局
未报告次要终点