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临床试验/CTRI/2025/09/093955
CTRI/2025/09/093955尚未招募1 期

Randomized Double Blind Study To Compare Hemodynamic Profile Of Intrathecal Hyperbaric Bupivacaine 0.5 percent Versus Hyperbaric Levobupivacaine 0.5 percent in Elderly Population Undergoing Infraumbilical Surgeries.

Bharati Hospital and Research Centre, Pune1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年9月10日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To compare hemodynamic parameters(SBP/DBP/MAP) of intrathecal hyperbaric Bupivacaine 0.5 percent with hyperbaric Levobupivacaine 0.5 percent post spinal anaesthesia in ASA II and III elderly population undergoing infraumbilical surgeries.

研究概览

简要总结

Spinal anaesthesia has been a popular anaesthesia technique. Hyperbaric

racemic bupivacaine is commonly used for spinal anaesthesia due to its

long duration of action and combined motor and sensory blockade.

However, the use of hyperbaric racemic bupivacaine in spinal anaesthesia

has some drawbacks. It has a high propensity to cause hypotension and

bradycardia following intrathecal injection and there is likely potential

for cardiac toxicity due to the high affinity of bupivacaine to cardiac

myocytes.

Levobupivacaine has a lower affinity for cardiac sodium channels and

greater plasma protein binding affinity compared with the dextro isomer

so reducing the risk of cardio-toxicity and decreasing the incidence of

hypotension and bradycardia.

Levobupivacaine also results in earlier motor recovery compared with

bupivacaine and also has less central nervous system toxicity.

These advantages make Levobupivacaine an safer alternative to

bupivacaine for spinal anaesthesia in high risk and elderly population.

It is currently known that levobupivacaine and bupivacaine have similar

analgesic potentials for Central Neuroaxial block and Peripheral Nerve

block.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • 1.Patients with ASA grade II,III.
  • 2.Patient undergoing elective infra umbilical surgeries in supine position under Spinal anesthesia.

排除标准

  • 未提供

结局指标

主要结局

To compare hemodynamic parameters(SBP/DBP/MAP) of intrathecal hyperbaric Bupivacaine 0.5 percent with hyperbaric Levobupivacaine 0.5 percent post spinal anaesthesia in ASA II and III elderly population undergoing infraumbilical surgeries.

时间窗: From 1 minute of administration of spinal anaesthesia till one hour

次要结局

  • To campare requirement of vasopressor between two groups(From 1 minutes of spinal anaesthesia till end of surgery)
  • To compare Duration of analgesia between the two groups(From 1 minute of spinal anaesthesia till 1 day)

研究者

发起方
Bharati Hospital and Research Centre, Pune
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Prithvi Dupare

BHARATI VIDYAPEETH (DEEMED TO BE UNIVERSITY) MEDICAL COLLEGE, PUNE, MAHARASHTRA.

研究点 (1)

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