Target controlled infusion with propofol in laparoscopic surgeries-a randomised controlled double-blind study of haemodynamic effects with fixed dose intravenous infusion of fentanyl or dexmedetomidine
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Stability of haemodynamic parameters during laparoscopy (with changes in mean arterial pressure as primary objective)
研究概览
简要总结
This study is a randomised controlled double blinded study,compares the haemodynamic effects i.e mean arterial pressure as primary outcome in TIVA anaesthetic technique with TCI propofol wherein comparator group fixed dose of intravenous infusion of fentanyl and in intervention group fixed dose intravenous infusion of dexmedetomidine is used in laparoscopic surgries.The secondary outcomes that will be studied are correlation of state entropy values and TCI propofol,total dosage of propofol used and assesment of postop nausea and vomiting.
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
- •American society of Anaesthesiologists physical status 1 to 2 Non obese(BMI 18.5 to 29).
排除标准
- •Refusal of patient consent Patients with significant systemic diseases Patients on long term and concurrent sedative intake.
结局指标
主要结局
Stability of haemodynamic parameters during laparoscopy (with changes in mean arterial pressure as primary objective)
时间窗: 1)on arrival to operating room,2)after bolus doses of test drugs,3)pre induction,4)post intubation (1 min, 2min, 5min,10min),5)at initiation of pneumo insufflation, 6)post pneumo- insufflation, 7)every 5 minutes till end of procedure;8)after removal of trocar, 9)stop of propofol infusion , 10)administration of reversal, 11)at extubation, 12)1 min, 2min, 5min and10min following extubation till shift out to Post anesthesia care unit (PACU)
次要结局
- correlation of TCI propofol with the state entropy levels i.e the effecctor site concentration value of propofol and corresponding state entropy values(Effector site concentration of propofol and corresponding state entropy values measured)
- total propofol dose used(at the end of surgery)
- Postop nausea and vomiting assesment in PACU and postop wards by PONV Impact scale (4 point likert scale) along with vomiting counts(IN PACU AND postop wards,every 2nd hourly for 24 hours)