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临床试验/CTRI/2024/03/063415
CTRI/2024/03/063415招募中Phase 3 4

Comparative study of subarachnoid block with 0.75% hyperbaric ropivacaine plus clonidine versus 0.5% hyperbaric bupivacaine plus clonidine in surgeries of lower limbs and lower abdomen

Bharti1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月13日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Severity of Pain assessment using VAS pain score

研究概览

简要总结

This study is a comparative randomized double blinded study between a newly introduced drug 0.75% hyperbaric ropivacaine with old drug 0.5% hyperbaric bupivacaine. Effect of clonidine as an adjuvant will also be assessed with respect to each drugs. This study will help us to improve the effectiveness of spinal anaesthesia during lower limbs and lower abdominal surgeries. Total 90 patients will be randomly selected of age group >18 years of either gender belongs to ASA grade I and II. 90 patients will be divided into two groups 45 in each by using sealed envelope technique. One group will receive 3 ml of 0.75% ropivacaine plus 45 micrograms clonidine and other will receive 3 ml of 0.5% bupivacaine plus 45 micrograms clonidine and will be given to patients via spinal anaesthesia under all aseptic precautions.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Any patients belongs to ASA grade I and II scheduled to undergo any major surgeries involving lower limbs and lower abdomen.

排除标准

  • ASA grade III and IV BMI more and equal to 30 General contraindications to spinal anaesthesia.

结局指标

主要结局

Severity of Pain assessment using VAS pain score

时间窗: Intra-operatively every 30 minutes till the duration of surgery | Post-operatively at 2, 4, 6, 8 and 12 hours

次要结局

  • 1. Total requirement of Injection Tramadol(2. Hemodynamic changes)

研究者

发起方
Bharti
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Bharti

SGT University

研究点 (1)

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