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临床试验/CTRI/2025/12/098509
CTRI/2025/12/098509尚未招募不适用

Comparison of Haemodynamics Between Fractionated and Bolus Injection in Spinal Anaesthesia for Elderly Patients: A Randomized Controlled Trial

Dr Mohanapriya S1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月26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

研究概览

简要总结

Informed written consent will be taken from all the patients

Patients will be randomly divided into 2 group , Group F ( Two third dose (2ml) injected initially 90 sec gap and remaining one third dose(1ml) given and Group B ( 3ml will be given 2.5ml of o.5%  hyperbaric bupivacaine with 0.5ml of fentanyl 25 microgram  Utilising a computer generated  table of random numbers before starting the procedure with concealment by sealed envelope method

on the day of surgery , patient shifted onto the operating room and monitor attached .

In the both spinal anaesthesia will be performed by anaesthesiologist

patient in sitting position at L3-L4 space with using 25 Guage Quincke spinal needle on each group . first 500ml of ringer lactate solution bolus over 30minutes followed by 500ml/hr onflow .

If MAP less than 65 mmHg iv fluid 100ml within 10 mins if still reduced then phenylephrine 20 microgram iv will be given ( total dose will documents till MAP become more than 65 mmHg. Data documentation primarily hemodynamics monitoring . every 2mins for  first 10 minutes then every 5 minutes for next hours then every 15mins for 4 hours followed by every 4 hours up to 24 hours postoperatively .secondary outcomes as from intraoperatively , onset evaluated by loos of cold sensation ( sensory block ) and onset of motor block by modified Bromage score and two segment regression time.

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
65.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • 1 Age Above 65 Years 2 ASA Grade I,II,III 3 Patient Consent.

排除标准

  • 1 CONTRAINDICATION TO SPINAL ANAESTHESIA 2 CARDIOVASCULAR DISEASES( ISCHEMIC HEART DISEASE) 3 CEREBROVASCULAR DISEASE 4 SPINE TO DEFORMITIES 5 ALLERGY TO STUDY DRUGS.

研究者

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

Dr Mohanapriya S

SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE

研究点 (1)

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