A prospective randomised comparative study to evaluate the effect of dexmedetomidine based on total body weight and ideal body weight.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The ideal weight scalar for assessing dose of intravenous dexmedetomidine for the haemodynamic stability during general anaesthesia during the duration of laprascopic surgery
研究概览
简要总结
This is prospective randomised comparative study to evaluate optimal intravenous dose of dexmedetomidine ( bolus and maintenance) based on total body weight and ideal body weight for laparoscopic surgeries.
Many drugs behave differntly in obese and non obese patients, the reason being both pharmacokinetics and pharmacodynamics properties of drugs. Dexmedetomidine may have varied effects in obese and non obese patients. There is no common consensus or literature retgarding correct weight scalar for dosing dexmedetomidine. There is no proportionate linear relationship in the increament of total body weight , adipose tissue and other body compartments like muscle , tissues etc. The volume of distribution also different and thus the drug dosing differs in obese patients. Hence we would like to evaluate the best weight scalar for bolus and maintenance dose of dexmedetomidine.
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
- •1 Patients undergoing elective laparoscopic surgery 2 With BMI between 30kg/m2 and above 3 ASA 1and 2 under general anaesthesia 4 Duration of 30 minutes to maximum of 3 hours 5 Informed consent.
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 dexmedetomidine .
- •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.
结局指标
主要结局
The ideal weight scalar for assessing dose of intravenous dexmedetomidine for the haemodynamic stability during general anaesthesia during the duration of laprascopic surgery
时间窗: Intraoperatively during surgery
次要结局
- Recovery parameters like(1 Sedation score post extubation)