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临床试验/CTRI/2025/08/093219
CTRI/2025/08/093219尚未招募不适用

Comparative study of hemodynamic effects of bolus and fractionated doses of spinal anesthesia in high risk patients undergoing lower limb surgeries A Randomised controlled double blind prospective study

Sdm college of medical science1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月10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
100
试验地点
1
主要终点
At the end of the study we anticipate a clear cut hemodynamic stability in high risk patients till 24 hours

研究概览

简要总结

Ethical committee approval taken. Patient informed consent taken. Patient of ASA3 and 4 groups undergoing lower limb surgeries  are randomly allocated into  2 groups by computer based allocation. 2 groups

Group B- Bolus dose of bupivacaine heavy 0.5% 0.2mg/kg with 0.5mcg/kg buprinorphine according to ideal body weight

Group F-- fractionated dose of bupivacaine heavy 0.5% 0.2mg/kg with 0.5mcg/kg buprinorphine according to ideal body weight 2/3rd followed by 1/3rd dose 60 seconds apart.

Blood pressure and time of achieving T10 sensory level and bromage 4 is noted and time of regression of sensory level by 2 dermatomes is noted and bromage 0 is noted.

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
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients belonging to ASA 3 And ASA 4 groups Patients undergoing lower limb surgery.

排除标准

  • Patients not belonging to ASA 3 And ASA 4 groups Patients not undergoing lower limb surgery Patients less than 40 years of age.

结局指标

主要结局

At the end of the study we anticipate a clear cut hemodynamic stability in high risk patients till 24 hours

时间窗: At the end of the study we anticipate a clear cut hemodynamic stability in high risk patients till 24 hours

次要结局

  • Increased duration of sensory & motor blockage till twentyfour hours(Increased duration of sensory & motor blockage till 24 hours)

研究者

发起方
Sdm college of medical science
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Spandana gs

SDM college of medical science and hospital

研究点 (1)

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