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临床试验/CTRI/2023/09/057384
CTRI/2023/09/057384尚未招募2 期

A Comparison of the injection rate of local anaesthetic during spinal anesthesia on the onset of sensory block and incidence of hypotension in Caesarean section

Civil hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Time to reach level of sensory block at T6

研究概览

简要总结

Spinal anesthesia is the most common anesthesia for Caesarean section due to lower exposure of the fetus to drugs, creating profound sensory and motor block as well as low risk of pulmonary maternal aspiration. Many factors such as type of local anesthetic, dose, rate of injection, volume of subarachnoid space, patient’s position play a role for adequate sensory block level in caesarean section with spinal block. Hypotension is the most common complication of spinal anesthesia. The most feared effect of hypotension is that it may lead to fetal hypoxia and acidosis by reducing uteroplacental perfusion if not treated timely.  In current study, we hypothesized that there may be delay in reaching the level of sensory block with turbulent flow caused by rapid local anesthetic injection. We aimed to investigate the effects of 2 injection rates that is not close to each other to achieve a sensory block level and intraoperative maternal hypotension and any other complications in elective caesarean section surgeriese

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 40.00 Year(s)(—)
性别
Female

入选标准

  • 1 Patients willing to consent for the study 2 Elective caesarean section delivery 3 American Society of Anaesthesiologists class I, II, III 4 Age 18 – 40 years 5 Singleton pregnancy.

排除标准

  • 1 Pregnant patients with contraindications for spinal anaesthesia 2 Placental anomaly 3 Hypertension 4 Known case of cardiac, hepatic, renal disease, vascular disease 5 Hemodynamic instability 6 Spinal deformity •Patients with weight <50kg or > 80kg and Height <140cm or >160cm.

结局指标

主要结局

Time to reach level of sensory block at T6

时间窗: From Time to inject the drug & time to get level of sensory block at T6, time to achieve complete motor block

次要结局

  • maternal hypotension, any other complications(from time to inject the drug up to the postoperative one hour)

研究者

发起方
Civil hospital
申办方类型
Government medical college

研究点 (1)

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