comparison of intravenous midazolam and dexmedetomidine as premedication in laproscopic cholecystectomy in bispectral index guided propofol induction of anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To compare the induction dose of propofol , in the three groups , midazolam , dexmedetomidine and the control group
研究概览
简要总结
Surgery and anaesthesia is a stressful condition and areassociated with stimulation of neuroendocrinal pathway, producing varioushemodynamic effects, which may be harmful for the patient. Methods to decreasethese effects include maintaining an adequate depth of anaesthesia to preventthese hemodynamic effects, or to give some pharmacological preparation to thepatients, which will modify the response of anaesthetic drugs
Premedication is a part of pre-anaesthesia preparation whichaims to prepare patients both physically and mentally for anaestheticprocedures. The main goal of pre-treatment is to eliminate anxiety. There areseveral classes of drugs used for the purposes of premedication, includingsedatives, alpha-2 adrenergic agonists, anticholinergics, narcotics,antihistamines, antacids, and H2 antagonists
Included in the sedative group are barbiturates,benzodiazepines, and butyrophenones. Midazolam belongs to benzodiazepine group,which is water soluble. It is short acting, widely used as an anxiolytic,sedative, and anaesthetic adjuvant, and has numerous advantages, such as ashort elimination half-life, a significant anterograde amnesia, mildrespiratory depression, and a relief of anxiety
Dexmedetomidine is a highly selective alpha 2 adrenergicreceptor agonist and possesses the potential benefit of sedation,sympatholysis, analgesia, and cardiovascular stability, Its hemodynamic effectsare predictable and dose dependent. Dexmeditomidine, at clinically effectivedosages, does not depress respiration, and therefore does not interfere withextubation
Laparoscopic surgery is a modern surgical technique involvinginsufflation of gas (usually CO2) into the peritoneal cavity under pressure toseparate organs from abdominal cavity. Laparoscopic cholecystectomy hasrevolutionized gall bladder surgeries and it has now become the gold standard forthe treatment cholelithiasis
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator 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
- •Patient scheduled for elective laproscopic cholecystectomy
- •age 18-60 years
- •both genders
- •ASA grade 1 and 2.
排除标准
- •Patients refusal to participate in study
- •Morbid obesity BMI >30
- •History of sleep apnoea
- •Pharmacological therapy.
- •Benzodiazipines, opoids , antipsychotics
- •anticipated difficult intubation
- •Sinus bradycardia or bundle branch block on ECG
- •Pregnant females
- •coagulopathy or bleeding diathesis
- •history of hypertension , diabetes mellitus, thyroid disease.
- •history of CNS , cardiovascular and renal diesease.
结局指标
主要结局
To compare the induction dose of propofol , in the three groups , midazolam , dexmedetomidine and the control group
时间窗: We will monitor Heart Rate, Blood Pressure, Oxygen saturation ,Bispectral Index Value at - | Preoperative period | Preinduction period | Preintubation . | At The Time of intubation. | Post intubation every minute till 10 minutes then | every 10 minute till the end of surgery | then we will monitor the outcome with modified Aldrete score post operatively.
次要结局
- 1. To compare the haemodynamic changes between different groups during intubation.(2. To compare the recovery profile between different groups.)