跳至主要内容
临床试验/CTRI/2021/09/036325
CTRI/2021/09/036325尚未招募不适用

Comparison of Premixed vs Sequential Administration of Fentanyl as an Adjuvant to Low dose Intrathecal Hyperbaric Bupivacaine in Lower Segment Cesarean Section

Teerthanker Mahaveer Medical College and Research centre Moradabad UP1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月9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
60
试验地点
1
主要终点
1.To compare the hemodynamic parameters between premixed and sequential group.

研究概览

简要总结

Hyperbaric Bupivacaine  is the most commonly used local anesthetic for spinal anesthesia.

As it is heavier than CSF, it generally settles down. Giving low dose of Hyperbaric Bupivacaine will reduce  the incidence of Hypotension. and combining it with Fentanyl, which is an opioid will prolong the effect and duration of anesthesia and will provide better analgesia. Also, it will be good for the Parturients as low dose of bupivacaine is used (7.5mg)

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 and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1.American Society of Anaesthesiologists (ASA) physical status I or II undergoing Lower Segment Cesarean Section.
  • 2.Patient between the age group of 18-40 years.

排除标准

  • 1.Patient with contraindication for spinal anaesthesia.
  • 2.Height less than 150 cms.
  • 3.Patient having severe pregnancy induced hypertension (PIH), intrauterine deaths or unknown fetal anomaly.
  • 4.Patients allergic to any medications.
  • 6.Patients with associated liver/renal/cardiac/pulmonary disease.

结局指标

主要结局

1.To compare the hemodynamic parameters between premixed and sequential group.

时间窗: Hemodynamic parameters at 5,10,15,20,25,30,40,50,60,70,80 minutes

2.To compare the onset and duration of sensory block between both group.

时间窗: Hemodynamic parameters at 5,10,15,20,25,30,40,50,60,70,80 minutes

3.To compare the onset and duration of motor block between both group.

时间窗: Hemodynamic parameters at 5,10,15,20,25,30,40,50,60,70,80 minutes

次要结局

  • 1. To record APGAR score at 1 min and 5 min respectively(2. To record any complications if any)

研究者

发起方
Teerthanker Mahaveer Medical College and Research centre Moradabad UP
申办方类型
Private medical college

研究点 (1)

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