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临床试验/CTRI/2025/06/089344
CTRI/2025/06/089344尚未招募Phase 3 4

Intrathecal 0.75% Isobaric Ropivacaine versus 0.5% Hyperbaric Bupivacaine in transurethral resection of Prostate Surgery

Sudha Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Our primary objective is to evaluate the efficacy of two different drugs of same group (alpha2 adrenergic agonist) clonidine & dexmedetimidine in combination with 0.5% hyperbaric bupivacaine via intrathecal route with regard to the quality of anaesthesia namely time to attain highest sensory and motor blockade, haemodynamic changes and time to first rescue analgesia.

研究概览

简要总结

unless contraindicated, almost all the lower abdomen and lower limb surgeries are done under spinal anaesthesia using hyperbaric bupivacaine. To prolong the sensory and motor blockade duration following spinal anaesthesia various additives has been used historically, here in our study i am going to compare alpha 2 agonist clonidine and dexmedetomidine as a spinal additive in prolonging the duration of spinal analgesia, hemodynamic fluctuations and its effects on sedation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

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

入选标准

  • 1.Age 20-60yrs 2.ASA grade 1 & 2 3.Willing patients.

排除标准

  • 1.Uncooperative patients 2.Uncontrolled DM and SHTN 3.Allergy to study drugs 4.Height <150cms 5.Contraindication to spinal anaesthesia 6.Patient refusal 7.Infection at injection site 8.Increased intracranial pressure 9.Indeterminate neurological diseases 10.Coagulopathy.

结局指标

主要结局

Our primary objective is to evaluate the efficacy of two different drugs of same group (alpha2 adrenergic agonist) clonidine & dexmedetimidine in combination with 0.5% hyperbaric bupivacaine via intrathecal route with regard to the quality of anaesthesia namely time to attain highest sensory and motor blockade, haemodynamic changes and time to first rescue analgesia.

时间窗: WITHIN 24 HOURS

次要结局

  • sedatory effects of both drugs in the postoperative period.(5months)

研究者

发起方
Sudha Institute of Medical Sciences
申办方类型
Research institution and hospital

研究点 (1)

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