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临床试验/CTRI/2024/01/061409
CTRI/2024/01/061409已完成3 期

Comparative evaluation of block characteristics in the supine knee-chest position and supine position in parturients undergoing elective caesarean delivery under spinal anaesthesia

Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年1月31日最近更新:
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试验速览

阶段
3 期
状态
已完成
入组人数
33
试验地点
1
主要终点
Onset time of sensory block (measured from intrathecal drug administration till achievement of T6 block height) between supine knee-chest position and supine position in parturients undergoing caesarean delivery

研究概览

简要总结

In pregnant women with category 1 indication for caesarean delivery (immediate threat to life of parturient or foetus) rapid delivery of foetus is necessary. Such patients often receive general anaesthesia, as it is a time saving and a more reliable option compared to the spinal block. There is evidence that the onset of adequate surgical anaesthesia for caesarean delivery can be hastened by placing the patient in the knee-chest position for a minute immediately after performing the spinal anaesthesia in the sitting position. The haemodynamic effect of this technique was safe in the patient population.  There is paucity of literature that compares spinal block characteristics between supine knee-chest and supine positions in parturients undergoing caesarean delivery under spinal anaesthesia. The study hypothesis is that the supine knee-chest position shortens the onset time of sensory block compared with the supine position in parturients undergoing elective caesarean delivery under spinal anaesthesia. Therefore, we are conducting this study to assess the spinal block characteristics between supine knee-chest position and supine position in parturients undergoing elective caesarean delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • •American Society of Anesthesiologists physical status II women, with singleton term pregnancy, undergoing elective caesarean delivery under spinal anaesthesia.

排除标准

  • •Weight less than 50 kg or more than 100 kg, height < 140 cm and > 170 cm
  • •Known allergy to any study medication or any contraindication to spinal anaesthesia.

结局指标

主要结局

Onset time of sensory block (measured from intrathecal drug administration till achievement of T6 block height) between supine knee-chest position and supine position in parturients undergoing caesarean delivery

时间窗: Every 2 min after administration of spinal anaesthesia until there is no further rise in the block level for 4 minutes and at 5 minutes thereafter.

次要结局

  • 1.Maximum sensory block height and motor block(2.Incidence of hypotension and bradycardia and requirement of fluid and vasopressor)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Anmoldeep Kaur Sran

Vardhman Mahavir Medical College and Safdarjung Hospital

研究点 (1)

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