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临床试验/CTRI/2019/10/021537
CTRI/2019/10/021537尚未招募不适用

Comparison of analgesic and hemodynamic effect of nalbuphine vs fentanyl :A randomized double blind Interventional Study on cardiac surgical patients at SMS medical college and attached hospitals, Jaipur during 2018-2019

Department of anesthesiologySMS medical college jaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年7月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To assess and compare hemodynamic variables from baseline at different time interval in both groups.

研究概览

简要总结

In this study we aim to compare the effect of nalbuphine and fentanyl on hemodynamic parameters and BIS guided total analgesic dose required,time required of first rescue analgesic and side effects any.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Either sex
  • Age group 18-65yrs 3 .Body weight 40-70kg
  • ASA Grade II &lll
  • Scheduled for cardiac surgery on cardiopulmonary bypass.

排除标准

  • 1.Patients not willing to participate in study 2.Uncooperative patients 3.Patients with history of drug allergy 4.Patients with pre-existing, Asthma, Renal or Hepatic dysfunction 5.Morbid obese patient 6.Pregnancy/Lactation.

结局指标

主要结局

To assess and compare hemodynamic variables from baseline at different time interval in both groups.

时间窗: Data will be recorded baseline (before induction), just after intubation, 5 min and 15 min, 30 min after intubation nd after that 5 min before going on pump, 5 min after going on pump, every 30 min till shifted to icu.

Heart rate

时间窗: Data will be recorded baseline (before induction), just after intubation, 5 min and 15 min, 30 min after intubation nd after that 5 min before going on pump, 5 min after going on pump, every 30 min till shifted to icu.

Systolic blood pressure

时间窗: Data will be recorded baseline (before induction), just after intubation, 5 min and 15 min, 30 min after intubation nd after that 5 min before going on pump, 5 min after going on pump, every 30 min till shifted to icu.

Diastolic blood pressure

时间窗: Data will be recorded baseline (before induction), just after intubation, 5 min and 15 min, 30 min after intubation nd after that 5 min before going on pump, 5 min after going on pump, every 30 min till shifted to icu.

Mean Arterial Pressure

时间窗: Data will be recorded baseline (before induction), just after intubation, 5 min and 15 min, 30 min after intubation nd after that 5 min before going on pump, 5 min after going on pump, every 30 min till shifted to icu.

central venous pressure

时间窗: Data will be recorded baseline (before induction), just after intubation, 5 min and 15 min, 30 min after intubation nd after that 5 min before going on pump, 5 min after going on pump, every 30 min till shifted to icu.

次要结局

  • 1.To asses and compare BIS guided total requirement of analgesic drug in bothgroups(2.To assess and compare the time required for first rescue analgesic in both group in postoperative period after extubation according to VAS score.)

研究者

发起方
Department of anesthesiologySMS medical college jaipur
申办方类型
Government medical college

研究点 (1)

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