Comparative Study Between the Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Noninvasive mean blood pressure
研究概览
简要总结
This study will be carried out to compare the efficacy of dexmedetomidine, propofol or lidocaine infusions in attenuation of hemodynamic responses to pneumoperitoneum during adult laparoscopic cholecystectomy using electrical cardiometry.
详细描述
Many drug infusions have been used to control hemodynamic responses to laparoscopic surgeries like propofol, fentanyl, esmolol with varying degrees of success.
Dexmedetomidine has sedative and analgesic properties seems to be appropriate enough to control the sympathetic response as well as provide a stable hemodynamics
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists I patients.
- •Patients between the ages of ≥ 20 and ≤ 60 years of both sexes.
排除标准
- •Hypersensitivity to dexmedetomidine, propofol or lidocaine.
- •Diabetic patients (Hemoglobin A1C ≥ 7).
- •Hypertensive patients (Blood presssure ≥ 140/90 mmHg) or patients on medications that affect hemodynamics as clonidine, methyldopa, β blockers and calcium channel blockers.
- •Impaired liver function (serum albumin ≤ 3.5 g/dl, International normalized ratio≥ 1.3, total bilirubin >1mg/dl).
- •Impaired renal function (serum creatinine >1.2 mg/dl, blood urea >20mg/dl).
- •Morbidly obese patients with body mass index ≥
- •Patients with acute cholecystitis or active infection.
- •Patients taking medications that may impair cognition.
- •History of seizures.
研究组 & 干预措施
Control group
Patients will receive infusion of 25 ml normal saline in 50 ml syringe pump.
干预措施: normal saline (Drug)
Dexmedetomidine group
Patients will receive infusion of dexmedetomidine in the dose of 0.4 μg/kg/hr. One ml dexmedetomidine (100 μg/ml) will be diluted with 24 ml normal saline in 50 ml syringe pump to achieve dilution of 4 μg/ml.
干预措施: Dexmedetomidine (Drug)
Propofol
Patients will receive propofol infusion in the dose of 3 mg/kg/hr. (12) 25 ml propofol 1% (10 mg /ml) in 50 ml syringe pump
干预措施: Propofol (Drug)
Lidocaine
Patients will receive lidocaine infusion in the dose of 2 mg /kg/hr. (15) 25 ml lidocaine 1% (10 mg/ml) in 50 ml syringe pump.
干预措施: Lidocain (Drug)
结局指标
主要结局
Noninvasive mean blood pressure
时间窗: Intraoperatively
mean blood pressure will be noted by a standard automated multi channel monitor will be connected to each patient
次要结局
- Intraoperative rescue drugs(Intraoperatively)
- Post extubation sedation(24 hour postoperatively)
研究者
Ahmed Mohammed Nasar
Specialist
Menoufia University