跳至主要内容
临床试验/CTRI/2021/03/032460
CTRI/2021/03/032460尚未招募不适用

Comparative study of intrathecal 0.5% bupivacaine(12mg) versus 0.5% bupivacaine(8mg) with fentanyl(25µg) for ephedrine requirement in caesarean section

MS Ramaiah medical college1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年1月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
110
试验地点
1
主要终点
To assess the mean ephedrine requirement

研究概览

简要总结

Spinal anaesthesia is the most common method of regional block in caesarean section. It produces sympathetic block, sensory analgesia and motor block depending on the dosage, concentration or volume of local anesthetics used. The dose of local anesthetics used in spinal anaesthesia varies with height of the patient, desired segmental level, the specific gravity of the drug and use of adjuvants. The most unavoidable response of spinal anaesthesia is hypotension which directly correlates with the dose of local anaesthetics used.

The addition of opiods to local anesthetic for spinal anaesthesia was first introduced in 1979 with morphinre. Opioids are synergistic with local anesthetics and intensify the sensory block without increasing the sympathetic block. They are commonly used as adjuvants with local anesthetics for potentiating their effects , thus offering hemodynamic stability by reducing the dose and side effects of local anesthetics. In the literature very few studies have been done to assess the actual vasopressor requirement by addition of opioids. The aim of our work is to study the efficacy of intrathecal fentanyl as an adjuvant to low dose bupivacaine to conventional dose bupivacaine on vasopressor requirement in caeserean section.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Patients with ASA status I or II.

排除标准

  • 1.ASA III or IV 2.Patient refusal 3.Pregnancy related hypertension 4.Infection at the site of injection 5.Coagulopathy disorders 6.Allergy to local anesthetics 7.Musculoskeletal deformity.

结局指标

主要结局

To assess the mean ephedrine requirement

时间窗: Heart rate , Systolic Blood Pressure , Diastolic blood pressure and saturation will be recorded at 0 , 2, 4, 6, 8, 10, 12, 14, 20 , 25, 30, 35 minutes

次要结局

  • To assess - the sensory and motor level blockade(- duration of post-operative analgesia)

研究者

申办方类型
Private medical college

研究点 (1)

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