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临床试验/CTRI/2024/06/068884
CTRI/2024/06/068884尚未招募不适用

Comparative Study Of Intrathecal 0.5% Bupivacaine Heavy With Nalbuphine VS 0.5% Bupivacaine Heavy Alone In Lower Abdominal And Lower Limb Surgeries

MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月16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
Intrathecal bupivacaine 0.5 % heavy with nalbuphine is better than intrathecal bupivacaine 0.5 % heavy alone

研究概览

简要总结

After getting ethical clearance from ethical committee, 100 patients will be enrolled under ASA I , II , and III aged between 20-70 years scheduled for elective surgeries.

written and informed consent taken . pre aneathetic evaluation willl be done.All The patients will be given anxiolytics the previous night and the next day morning of surgery.

IV line with 18G cannula will be secured. The spinal anaesthesia procedure is standardized here : patient positioning is done in lateral decubitus under sterile aseptic precautions , spinal anaesthesia is performed at the L3-L4 lumbar space using a 25G Quinkes needle.

Group A recieved 15mg (3ml) of 0.5% Bupivacaine(H) and nalbuphine 0.8mg (0.5ml) - total volume of 3.5ml.

Grioup B recieved 15mg(3ml) of 0.5% bupivacaine (H) and normal saline 0.5ml (0.5ml) - total volume of 3.5ml.

oxygen at 4litres administered through face mask.

Hemodynamic parametres like peripheral oxygen saturation , non invasive blood pressure , pulse rate were recorded at regular intervals intraoperatively and post operatively upto 24hours

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age : 20 to 70 years ASA Physical status of Grade I ,II and III Patient who have valid informed and written consent Patients undergoing lower abdominal and lower limb surgery.

排除标准

  • Deranged coagulation profile Pregnant Patients.

结局指标

主要结局

Intrathecal bupivacaine 0.5 % heavy with nalbuphine is better than intrathecal bupivacaine 0.5 % heavy alone

时间窗: Once in a week

次要结局

  • To be observed(To be observed)

研究者

发起方
MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

BINDHU R V

MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL

研究点 (1)

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