A prospective randomised comparative study to evaluate optimal induction and maintenance dose of propofol according to total body weight,lean body weight and ideal body weight.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The ideal weight scalar for assessing the dose of propofol for induction and maintanence of total intravenous general anaesthesia in laprascopic surgery
研究概览
简要总结
This is a prospective randomised comparative study to evaluate optimal induction and maintenance dose of propofol according to total body weight, lean body weight and ideal body weight under total intravenous general anaesthesia for laprascopic surgery.
Many drugs behave differently in obese and non obese patients the reasons being both pharmacokinetics and pharmacodynamics properties of the drugs. Propofol is highly lipophilic agent and may have varied effects in the obese and the non obese patients. There is no common consensus or literature regarding correct weight scalar for dosing propofol. Presently propofol is administered by the total body weight which may be a very high dosage for obese patients. There is no proportionate linear relationship in the increment of total body weight, adipose tissue and the other body compartment like muscle, tissues etc. The volume of distribution also is different and thus the drug dosing differs in obese patients.
Hence we would like to evaluate the best weight scalar for dosing propofol for induction and maintenance of total intravenous general anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective laparoscopic surgery with BMI between 30 and 40, ASA 1and 2 under general anaesthesia for a minimum duration of 30 minutes to maximum of 3 hours.
排除标准
- •1.History of significant cardiac pulmonary, liver or renal disease.
- •Patient scheduled for awake bronchoscopic intubation.
- •Previous history of cerebrovascular accident, other neurological disorders and those on long term drugs affecting CNS (chronic BZD’s/ opioids)
- •Allergy to propofol.
- •Patients with significant hemodynamic changes intraoperatively, fall of Mean arterial blood pressure by more than 20% of baseline,intraoperative entropy of more than 60 for more than 10 minutes and need to add inhalational agent will be excluded.
- •patients refusal to be included in the study.
结局指标
主要结局
The ideal weight scalar for assessing the dose of propofol for induction and maintanence of total intravenous general anaesthesia in laprascopic surgery
时间窗: Industion dose- after one minute of injection of the bolus dose of intravenous propofol at induction of anaesthesia | maintenance dose- the average infusion dose for maintenance of anaesthesia with intravenous propofol throughout the duration of surgery, calculated at the end of the surgery
次要结局
- Recovery parameters like(1 Sedation score post extubation)