A comparative study of intravenous Fentanyl, Nalbuphine and Butorphanol on hemodynamic stress response to intubation and post-operative analgesia in modified radical mastectomy- A prospective randomized control study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Haemodynamic response to intubation-Heart rate,Systolic Blood pressure,diastolic blood pressure,mean arterial pressure,SPO2.
研究概览
简要总结
Opioids are popular and widely used adjuvant agent in conducting generalanasthesia. Fentanyl is extensively used due to its rapid onset of action, shorterduration of action and predictable pharmacokinetics and dynamics but it has tobe bought under opioid registry and have serious side effect of respiratorydepression. On the other hand, Nalbuphine and Butorphanol being partialagonist-antagonist at opioid receptors has no respiratory depression activityand are not under opioid regulation. But there are inadequate studies of safetyand efficacy of the above mentioned drugs in Indian population.so our aim ofthe study is to study the effect of equivalent intravenous dose of Fentanyl, Nalbuphine and Butorphanol on hemodynamic stress response due tointubation and post-operative analgesia in modified radical mastectomy(MRM)surgeries. Primary objective of our study is to compare the haemodyanamic response of Fentanyl, Nalbuphine and Butorphanol. Our secondary objective is to assess post-operativeanalgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients with breast carcinoma posted for modified radical mastectomy aged between 18-65 years ,giving valid informed consent belonging to ASA I and II.
排除标准
- •Patient refusal or patients in ASA III or IV grade or having history of allergy to opioid group of drugs.
结局指标
主要结局
Haemodynamic response to intubation-Heart rate,Systolic Blood pressure,diastolic blood pressure,mean arterial pressure,SPO2.
时间窗: Baseline,5 mins after drug,1 min after Intubation,3 mins after intubation,5 mins after intubation followed by every 30 minutes during surgery.postoperatively -after extubation,5 mins after extubation followed by every 30 minutes for next 6hours
post operative analgesia for 6 hours after completion of surgery.
时间窗: Baseline,5 mins after drug,1 min after Intubation,3 mins after intubation,5 mins after intubation followed by every 30 minutes during surgery.postoperatively -after extubation,5 mins after extubation followed by every 30 minutes for next 6hours
Visual analogue scale
时间窗: Baseline,5 mins after drug,1 min after Intubation,3 mins after intubation,5 mins after intubation followed by every 30 minutes during surgery.postoperatively -after extubation,5 mins after extubation followed by every 30 minutes for next 6hours
次要结局
- Post operative Analgesia-visual Analogue scale(VAS) for pain assessment,systolic blood pressure,diastolic blood pressure,mean blood pressure,respiratory rate,SPO2(6 hours postoperatively)