CTRI/2025/11/096998尚未招募2/3 期
Height weight adjusted dose versus fixed dose of hyperbaric bupivacaine in elective cesarean section to prevent maternal hypotension A prospective, double blinded, Randomized Controlled Study
Dhanya S1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年11月20日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To study the incidence of maternal hypotension in height - weight adjusted dose regimen group versus fixed dose group
研究概览
简要总结
To study the incidence of maternal hypotension in height-weight adjusted dosing regimen group versus fixed dosing group
To assess the time taken for sensory block uoto T6 level, assess motor block according to Modified Bromage scale, to assess the dose of mephentermine used in both the groups, to assess the incidence of complications like hypotension, bradycardia, shivering, nausea, and vomiting , to assess neonatal APGAR scores at 1 and 5 minutes in both the groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant woman classified as ASA 2 Pregnant woman carrying singleton pregnancy (more than 37weeks of gestation) Pregnant woman with weight 50-110kg and height of 140-180cm Patients who is scheduled for elective cesarean section.
排除标准
- •Pregnant belonged to ASA III or IV Patients having pre eclampsia and cardiac or respiratory diseases, gestational and pre diabetes Patient having IUGR, Fetal anomalies Patient having abruptio placenta, placenta previa,accreta, percreta Patients requiring emergency LSCS Patient declining participation.
结局指标
主要结局
To study the incidence of maternal hypotension in height - weight adjusted dose regimen group versus fixed dose group
时间窗: To note intraoperative vitals at 0,2,4,6,8,10,15,30,45,60 minutes
次要结局
- To assess the time taken to achieve sensory level upto T6 level in both the groups(To assess the time taken to attain motor block according to Modified Bromage scale in both the groups)
研究者
Dr Dhanya S
RajaRajeswari Medical College and Hospital
研究点 (1)
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