临床试验/CTRI/2024/07/071711

CTRI/2024/07/071711已完成不适用

A Comparative study of Intrathecal hyperbaric levobupivacaine 5 mg versus hyperbaric bupivacaine 5 mg in spinal anaesthesia for orthopaedic surgery.

Smt SCL General Hospital1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2024年8月15日最近更新: 2024年7月29日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 60
试验地点: 1
主要终点: MOTOR AND SENSORY BLOCK CHARACTERISTICS

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

THE STUDY WILL ONLY START AFTER I GET THE CTRI APPROVAL FOR THE STUDY. I WANT TO DO THIS RESEARCH TO GET TO KNOW THE BETTER DRUG FOR SPINAL ANAESTHESIA.

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, Investigator and Outcome Assessor 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

•ASA Grade 1 and 2 Elective lower limb orthopaedic surgeries.

排除标准

•Patient refusing to give consent Known hypersensitivity to study drugs Respiratory, Cardiovascular, Renal or Hepatic disease(ASA Grade 3 and 4) Blood Coagulopathies Patient with peripheral neuropathy Patient with local sepsis or spinal deformity.

结局指标

主要结局

MOTOR AND SENSORY BLOCK CHARACTERISTICS

时间窗: 1 Time required to achieve sensory block up to T10 level. | 2 Time required to achieve maximum level of sensory block. | 3 Time required to achieve modified bromage scale.

次要结局

HEMODYNAMIC STABILITY DURING INTRAOPERATIVE PERIOD (PULSE RATE, BLOOD PRESSURE & SPO2 MONITORING)(Baseline,)
QUALITY OF ANAESTHESIA(Excellent)
COMPLICATIONS(Hypotension)
DURATION OF BLOCK(Complete recovery of sensory block)

研究者

发起方

Smt SCL General Hospital

申办方类型

Other [corporation hospital]

责任方

Principal Investigator

主要研究者

Dr Ushma H Thakar

Smt NHL Municipal Medical College

研究点 (1)

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