跳至主要内容
临床试验/CTRI/2025/07/090764
CTRI/2025/07/090764招募中不适用

Postspinal Hypotension In Patients Of Preeclampsia: Randomised Comparison Of Equivalent Fall In Systolic Versus Mean Arterial Pressure For Effect On Neonatal Outcome

University College Of Medical Sciences and Guru Teg Bahadur Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Umbilical artery pH

研究概览

简要总结

The present study thus aims to compare two equivalent falls in systolic and mean arterial pressure for defining (and concomitantly treating) postspinal hypotension in patients of preeclampsia undergoing cesarean section, with regards to neonatal and maternal outcome.

Primary objective is to compare postspinal hypotension defined as  20% or more fall in systolic blood pressure or in mean arterial pressure, in patients of preeclampsia undergoing cesarean section with regards to umbilical artery pH.

Methods

The anesthetic management for these patients will be standardized as per routine practice. This will include standardized aspiration prophylaxis, non-invasive monitoring and single-shot spinal block using hyperbaric bupivacaine.

Systolic, diastolic and mean arterial pressures as well as heart rate will be measured every minute from the spinal injection until delivery of the baby. Hypotension after spinal anesthesia will be defined as a decrease in systolic arterial pressure of 20% or more from baseline for group S20; and similar fall in mean arterial pressure for group M20. Whenever postspinal hypotension occurs it will be treated with 50 microgm of phenylephrine (i.v.), repeated every minute, till the blood pressure rises above the hypotensive threshold.

Statistical analysis will be performed using SPSS (SPSS Inc., Chicago, IL, USA). Intergroup comparison will be done with Pearson’s Chi-square, Fisher’s exact test or Mann–Whitney U-test t-teat as appropriate, after testing for normal distribution using K-S test. Intergroup trends of arterial pressure and heart rate for the study period will be analyzed using mixed-model analysis, taking the best covariance structure based on Akaike’s information criterion (AIC).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor 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

  • Consenting women with preeclampsia scheduled for cesarean section under spinal anesthesia.

排除标准

  • Those known with chronic hypertension and other cardaic vascular disease, cerebro vascular disease, known fetal abnormalities or any contraindications to spinal block.

结局指标

主要结局

Umbilical artery pH

时间窗: At the time when baby is delivered (by cesarean section).

次要结局

  • Neonatal umbilical artery base excess(At the time when baby is delivered (by cesarean section).)

研究者

发起方
University College Of Medical Sciences and Guru Teg Bahadur Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

ASHA TYAGI

University College of Medical Sciences and Guru Teg Bahadur Hospital

研究点 (1)

Loading locations...

相似试验