A COMPARATIVE EVALUATION OF PROPOFOL- KETAMINE AND PROPOFOL – DEXMEDETOMIDINE IN TERMS OF HEMODYNAMIC VARIABLES AND RECOVERY CHARACTERISTICS IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY’’
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Which among the two drug combination has better hemodynamic stability and recovery characteristics. Comparison in terms of Intraoperative hemodynamic variables including heart rate , mean arterial blood pressure , systolic blood pressure, diastolic blood pressure and Recovery characteristics
研究概览
简要总结
This is a comparative study of two anaesthetic drug combination propofol-ketamine and propofol-dexmedetomidine in terms of hemodynamic variables like heart rate,blood pressure and recovery characteristics in two study groups of patients undergoing laparoscopic cholecystectomy under general anaesthesia. It will be conducted in department of anaesthesiology, JLNHRC and it is hospital based, time bound, prospective, comparative randomised control trial and sample size is 56 patients undergoing laparoscopic cholecystectomy. Two groups of 28 patients each will be made. After taking consent and pre anaesthetic checkup and preparation for ot, Patient will receive loading dose of either iv ketamine or iv dexmedetomidine before induction with propofol and surgery will be started. Intraoperative hemodynamic variables like heart rate , mean arterial blood pressure , systolic blood pressure, diastolic blood pressure will be measured every 10 mins interval till the end of surgery and Recovery characteristics including emergence time, response to commands time, orientation time, Ramsay sedation score at 0min 30 min 60 min 90 min 120 min; VAS score at 0 hour ,1 , 2, 3, 4, 6, 8,10, 12, 18, 24th hour; first analgesic time; recovery discharge time will be noted and compared as per the objective of the study. All data will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator 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
- •ASA I and ASA II Both genders Age from 18 years to 60 years Patients undergoing laparoscopic cholecystectomy.
排除标准
- •Age below 18 years and above 60 years ASA III and ASA IV Pregnant or breast.
- •feeding patient Patients with baseline heart rate less than 55/minute Patients with hypertension, heart blocks and ischemic heart diseases Allergic to study drugs Laparoscopic cholecystectomy converted to open cholecystectomy Patient with severe hepatic, renal, endocrine and cardiac dysfunction Patient refusal to participate in the study Patients on sedatives, psychiatric medications, opioid therapy.
结局指标
主要结局
Which among the two drug combination has better hemodynamic stability and recovery characteristics. Comparison in terms of Intraoperative hemodynamic variables including heart rate , mean arterial blood pressure , systolic blood pressure, diastolic blood pressure and Recovery characteristics
时间窗: Intraoperative heart rate , mean arterial blood pressure , systolic blood pressure, diastolic blood pressure measured every 10 mins interval . Recovery characteristics including emergence time, response to commands time, orientation time, Ramsay sedation score at 0min 30 min 60 min 90 min 120 min; VAS score at 0 hour ,1 , 2, 3, 4, 6, 8,10, 12, 18, 24th hour; first analgesic time; recovery discharge
次要结局
- Hemodynamics , Recovery profile, post operative analgesic requirement, PACU stay(Intraoperative hemodynamic variables like heart rate , mean arterial blood pressure every 10 mins interval . Recovery characteristics including emergence time, response to commands time, orientation time, Ramsay sedation score at 0min 30 min 60 min 90 min 120 min; VAS score at 0 hour ,1 , 2, 3, 4, 6, 8,10, 12, 18, 24th hour; first analgesic time; recovery discharge)