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临床试验/CTRI/2022/05/042386
CTRI/2022/05/042386尚未招募不适用

Spinal block with 0.75% Ropivacaine heavy versus 0.5% Bupivacaine heavy for short urological procedures in elderly population: A Randomized, Comparative and Controlled study

Nidhi Arun1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年10月5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
90
试验地点
1
主要终点
1.Time of onset of sensory block (minutes)

研究概览

简要总结

0.5% Bupivacaine has been widely used for spinal anaesthesia. However, it is associated with various side effects like, prolonged motor blockade, urinary retention, cardio-vascular as well as central nervous system toxicity due to its high lipid solubility. Short length of carbon chain makes ropivacaine less lipid soluble. Being less lipophilic, Ropivacaine has less cardio-toxicity and more selective sensory versus motor toxicity. With this background we are undertaking this study to verify the beneficial properties of hyperbaric ropivacaine in elderly patients posted for short urological procedures under spinal block.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
50.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients of age ≥50 years
  • ASA Grade-I & II
  • Undergoing short urological procedures under SAB.

排除标准

  • Patient refusal
  • ASA Grade-III & IV
  • Unstable hemodynamic status
  • Allergic to study agents
  • Any contraindication to SAB
  • Coagulopathy •Prolonged urological procedures requiring conversion to general anaesthesia or any anaesthetic supplementation •Mental disorders, such as schizophrenia and psychosis on long-term psychotropic drugs.

结局指标

主要结局

1.Time of onset of sensory block (minutes)

时间窗: After the spinal block is given and during the surgical procedure at 15 minutes interval

2. Maximum cephalic spread (dermatome)

时间窗: After the spinal block is given and during the surgical procedure at 15 minutes interval

3. Time to maximum cephalic spread (minutes)

时间窗: After the spinal block is given and during the surgical procedure at 15 minutes interval

8. Degree of block assessed by Bromage scale

时间窗: After the spinal block is given and during the surgical procedure at 15 minutes interval

4. Two segment regression time (minutes)

时间窗: After the spinal block is given and during the surgical procedure at 15 minutes interval

7. Total duration of sensory block (minutes)

时间窗: After the spinal block is given and during the surgical procedure at 15 minutes interval

9. Intra-operative vital parameters

时间窗: After the spinal block is given and during the surgical procedure at 15 minutes interval

次要结局

  • 1. In recovery room pulse rate, blood pressure, respiratory rate and SPO2 will be monitored(2. Time of need of analgesia by patients)

研究者

发起方
Nidhi Arun
申办方类型
Other [self]

研究点 (1)

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