A comparative evaluation of oral pregabalin and clonidine for attenuation of haemodynamic response to laryngoscopy and tracheal intubation during laparoscopic cholecystectomy
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of oral pregabalin and Clonidine in attenuating the hemodynamic responses to laryngoscopy and intubation.
研究概览
简要总结
The present study is designed to compare the efficacy of oral pregabalin vs clonidine for attenuation of haemodynamic response to laryngoscopy and tracheal intubation in patients undergoing laparoscopic cholecystectomy under general anaesthesia. Haemodynamic changes (HR, SBP, DBP, MAP) following laryngoscopy and intubation will be recorded and compared between the groups. The study is conducted in 80 patients aged 18-65 years with ASA grade 1 or 2 of both gender admitted in VMMC and Safdarjung hospital. patients are divided into two groups, group P - pregabalin and group C - clonidine. patient in group P will receive 75mg oral pregabalin tablet and in group C will receive 200mcg clonidine tablet 90 minutes before surgery with sip of water. A detailed preanaesthetic evaluation including all routine investigations as guide by age will be carried out in all patients. Patients excluded from the study are:
1-anticipated difficult airway.
2-subjects with BMI>30.
3-patients concomitantly on clonidine or pregabalin or consumption of antihypertensive drugs, sedatives or hypnotics.
4-patients with history of cardiovascular, cerebrovascular, neurological and respiratory, renal and hepatic dysfunction.
5-patients with history of allergic reaction to any of the study drugs.
In OT, standard monitoring including Spo2, NIBP, ECG, HR and sedation level will also be noted. patient will be given fentanyl 2mcg/kg IV and after 3-5 minutes induced with propofol 2-2.5mg/kg IV followed by injection Vecuronium 0.1mg/kg, IPPV with N2O with O2 with isoflurane 0.6% at flow rate of 6L/min, 3 minutes later laryngoscopy and intubation will be performed. haemodynamic parameters will be noted before induction, immediately after induction, 3 minutes after induction and 1,3,5 and 10 minutes after intubation. Anesthesia will be maintained with 66% N2O with O2 and isoflurane 0.6%. At the end of surgery, inhalational anaesthetic agent will be stopped, neuromuscular blockade reversed with inj glycopyrolate 0.01mg/kg and inj neostigmine 0.05mg/kg and trachea extubated. patient will be shifted to postoperative care unit when fully conscious and vitals stable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Undergoing elective Laparoscopic cholecystectomy.
- •ASA I and II.
排除标准
- •Anticipated difficult intubation.
- •BMI more than
- •Patient concomitantly on Clonidine or Pregabalin or on Anti hypertensive drugs, Sedatives or hypnotics.
- •Patients with history of cardiovascular , cerebrovascular, neurological and respiratory disease, renal and hepatic dysfunction.
- •Patients with history of allergic reactions to any of the study drugs.
结局指标
主要结局
To evaluate the efficacy of oral pregabalin and Clonidine in attenuating the hemodynamic responses to laryngoscopy and intubation.
时间窗: Before premedication (T0). | Preinduction (TPREI). | Immediately after induction (TP0I). | 3 minute after induction (TP0I3). | 1(TT1), 3(TT3), 5(TT5) and 10(TT10) minutes after intubation
次要结局
- to compare the efficacy of Oral pregabalin and clonidine in attenuating the hemodynamic responses to laryngoscopy and intubation(Before premedication.)