跳至主要内容
临床试验/CTRI/2022/03/040877
CTRI/2022/03/040877尚未招募不适用

"A prospective,randomized,double blind study comparing intrathecal hyperbaric levo bupivacaine with plain levo bupivacaine in infra umblical surgeries"

Sir Gangaram Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年3月26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
40
试验地点
1
主要终点
Time to obtain maximum sensory block.The highest level of sensory block.Two segment regression of sensory block.The degree of maximum motor block.The end time of motor block.

研究概览

简要总结

Spinal anaesthesia is a common and established technique for providing anaesthesia for infraumblical surgeries, i.e. surgeries below naval like haemorrhoidectomy, inguinal herniorrhaphy, transurethral retropubic prostatectomy, caesarean section or surgeries on lower limbs like debridement and amputation. In this type of anaesthesia patient is awake, does not go to sleep.It has its own benifits. The patient can be discharged from hospital on the same day.That will help the patient from extra expences and long stay in hospital.Spinal block is safe, effective and easy to perform technique.Spinal anaesthesia requires smaller dose of local anaesthetics and produces intense blockade. Levobupivacaine is an isomer, S[-] enantiomer of bupivacaine. It is less cardiotoxic and neurotoxic than bupivacaine which is commonly used in spinal anaesthesia.

We intend to study the effects of hyperbaric levobupivacaine and plain levobupivacaine in spinal anaesthesia in patients . It has better safety profile than bupivacaine and hence a better choice if drug.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adult patients of either gender aged 18-60 years ASA 1-ASA 3 patients Infraumblical surgeries under spinal anaesthesia.

排除标准

  • Past history of spine surgery Infective focus at site of injection Coagulopathy Obesity BMI> 30 Short height< 150 cm Unwilling patients Pregnancy Lower limb paresis History of arrhythmias.

结局指标

主要结局

Time to obtain maximum sensory block.The highest level of sensory block.Two segment regression of sensory block.The degree of maximum motor block.The end time of motor block.

时间窗: Onset, every 5 minutes ,every 15 minutes, 1 hour,2 hours , 3 hours

次要结局

  • Heart rate changes(Peripheral oxygen saturation changes)

研究者

发起方
Sir Gangaram Hospital
申办方类型
Research institution and hospital

研究点 (1)

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