Comparison of intravenous Dexmedetomidine with Midazolam in prolonging spinal anaesthesia with Ropivacaine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time for onset of analgesia ( highest level assessed by bilateral pin prick )
研究概览
简要总结
In the present clinical study, we compare the effects of intravenous dexmedetomidine with midazolam on spinal block duration, sedation and post operative analgesia. Whereas Midazolam is only a sedative, Dexmedetomidine has both analgesic and sedative properties that may prolong the duration of sensory and motor block obtained with spinal anaesthesia.60 ASA grade I & II patients scheduled for lower limb and lower abdominal surgeries in Govt. Medical college/Rajindra hospital, Patiala will be randomly allocated to three groups of 20 each. Immediately after 3ml of 0.5% ropivacaine given intrathecally,
Group D (n=20): will be administered i/v dexmedetomidine (a loading dose of 1 µg/kg over 10 min and a maintenance dose of 0.5 µg/kg/hr in form of infusion)
Group M (n=20): will be given midazolam (loading dose of 0.05 mg/kg followed by infusion@0.02 mg/kg/hour), and ,
Group C (n=20): will receive the normal saline.
Intraoperative haemodynamic changes, onset, level & duration of sensory block, onset and duration of motor block, level of sedation, postoperative analgesia & side effects, if any will be recorded. All findings and information, including the time for the first request for postoperative analgesia and the number of patients requiring supplemental analgesia will be recorded. All results will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant 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 I and II Patients undergoing lower limb and lower abdominal surgery Body mass index of 30 or less Normal coagulation profile.
排除标准
- •Unwilling patient, history of chronic illness, spinal abnormality, local skin infection, coagulation defects, Recent MI, Allergy to the drugs being used.
结局指标
主要结局
Time for onset of analgesia ( highest level assessed by bilateral pin prick )
时间窗: Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
Peak sensory level reached
时间窗: Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
Time taken for sensory block regression by 2 dermatomes, Time taken for motor block to recede to Bromage and Postoperative
时间窗: Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
Sedation produced by the two groups,
时间窗: Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
Haemodynamic profile of the two groups ,
时间窗: Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
Need of additional analgesic
时间窗: Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
, Incidence of complications including depression, nausea, vomiting, pruritus, hypotension, bradycardia, shivering between the two groups
时间窗: Intraoperative ,Intraoperative, Postoperative, Postoperative, Intraoperative, every 5 minutes for the first 30 minutes and then every 10 minutes till the end of surgery and then at 4, 8, 12, 24 hours postoperatively, Intraoperative, Intraoperative and Postoperative
次要结局
- Time for onset of analgesia ( highest level assessed by bilateral pin prick )(Peak sensory level reached, Time taken for motor block to recede to Bromage and Postoperative)