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临床试验/CTRI/2025/08/093494
CTRI/2025/08/093494尚未招募4 期

Anaesthetic management of high risk orthopedic patients with combined sequential spinal epidural using three different doses of intrathecal ropivacaine

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
The primary objective is to compare the hemodynamic stability measured in terms of fall in MAP 30% from baseline.

研究概览

简要总结

Patients will be observed in terms of 3 groups namely Group 1 SAB with three and a half mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achieved Group 2 SAB with five mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achieved Group 3 SAB with seven and a half mg of ropivacaine heavy and epidural top up with half percent bupivacaine till T10 level is achievedAfter 2 segment regression epidural top ups will be given with bupivacaine half percent either one third  of the dose needed to achieve T10 level or 3 ml. The level of sensory block, modified Bromage motor scores MBS systolic blood pressure MAP and heart rate will be recorded for 30 min following anesthesia Peak sensory block height and MBS time for sensory regression to L1 and motor recovery to MBS 1 side effects and operator s satisfaction will be noted.Dural puncture will be performed at the L3 4 interspace with a 25 gauge Quincke tip spinal needle Next 0 5 percent hyperbaric ropivacaine will be given intrathecally in doses of 7 5 mg  11 25 mg and 15 mg in 3 groups namely groups 1 2 and 3 after the free flow of cerebrospinal fluid is observed The degree of sensory and motor block will be measured on the unoperated side of the limbs Surgery will be allowed to start as soon as the sensory block height reached the tenth thoracic dermatome T10 or 10 min had elapsed After 2 segment regression epidural top ups with bupivacaine 0 5 percent either 1/3 of the dose needed to achieve T10 level or 3 ml will be given,for the completion of surgery The orthopedic surgeons performing all the operations will grade the operator s satisfaction on a 5 point scale 5  very good 4  good 3  satisfactory 2 poor 1 very poor Similarly patient satisfaction will be noted down on a five point Likert scale Very satisfied Satisfied  Neither satisfied nor dissatisfied Dissatisfied and Very dissatisfied from a scale of 5 to 1

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant and Investigator Blinded

入排标准

年龄范围
65.00 Year(s) 至 95.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with ASA III & above 2.Heart disease with systolic & diastolic dysfunction 3.IHD with no indication/unwilling for pre-procedure intervention 4.Patients of either sex above 75 yrs of age irrespective of other comorbidities 5.Patients of uncontrolled DM 6.Elective /emergency surgery.

排除标准

  • 1.Patients <65 yrs 2.Contraindication of CSEA/SAB 3.Not willing.

结局指标

主要结局

The primary objective is to compare the hemodynamic stability measured in terms of fall in MAP 30% from baseline.

时间窗: Every 5 minutes, upto 30 minutes and then every 15 minutes till completion of surgery.

次要结局

  • 1. Incidence of bradycardia(2. Time needed to achieve bromage 3 (complete motor paralysis))

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Sathyasuba Meenakshi sundaram

BIHER

研究点 (1)

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