A Comparative Evaluation between Nalbuphine and Fentanyl with respect to induction dose of Propofol for patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia in a Tertiary Care Hospital in Sikkim - A Double Blinded Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Nalbuphine will be more effective than Fentanyl in reducing the induction dose of Propofol
研究概览
简要总结
A comparative evaluation between nalbuphine and fentanyl with respect to induction dose of propofol for patients undergoing laparoscopic cholecystectomy under general anaesthesia.
The objective of this study is to compare the dosage of propofol required for induction with pre - induction administration of two study drugs - nalbuphine and fentanyl and secondarily to assess the attenuation of stress response ( HR, BP, MAP, Spo2) to laryngoscopy and intubation between the two study drugs and lastly to assess any adverse effects intra- or post- operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Grade 1 and 2 patients undergoing elective laparoscopic cholecystectomy and providing written consent.
排除标准
- •ASA Grade 3 and 4 Pregnant females Patient refusal Patients allergic to or addicted to any drug used in trial ( nalbuphine, fentanyl or propofol).
结局指标
主要结局
Nalbuphine will be more effective than Fentanyl in reducing the induction dose of Propofol
时间窗: Nalbuphine will be more effective than Fentanyl in reducing the induction dose of Propofol which will be assessed after administering the propofol in the intra-operative period.
次要结局
- To assess which study drug helps in attenuating stable stress response (HR, BP , MAP & sPo2) to laryngoscopy & intubation.(After laryngoscopy & intubation, vitals will be monitored for every min for next 10 minutes & will be assessed within 24 hrs intraoperatively & post operatively.)
研究者
Dr Deepanshi Agrawal
Sikkim Manipal Institue of Medical Sciences