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临床试验/NCT05085652
NCT05085652已完成不适用

Is SARS-CoV-2 (Covid-19) a Risk Factor for Hypotension During Spinal Anesthesia for Obstetric Patients?

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2020年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
251
试验地点
1
主要终点
hypotension

研究概览

简要总结

Since the onset of COVID-19, recommendations suggest the use of neuraxial anesthesia, if possible, over general anesthesia for cesarian section to avoid the risks of aerosolization associated with tracheal intubation and extubation. But the safety of performing spinal anesthesia is unclear especially for post spinal hypotension, during the presence of active infection with COVID-19. Since at the beginning of the pandemic a few studies reported significant hypotension during epidural anesthesia in COVID-19 pregnant women, there was a controversial discussion about the safety of regional anesthesia was started. In this study we aimed to find if spinal anesthesia is safely recommended anesthesia type for COVID-19 obstetric patients. 249 patients with PCR confirmed COVID-19 for cesarean section undergoing spinal anesthesia in Ankara City Hospital, Ankara assessed in this retrospective study to find if the hypotension is the risk factor for the COVID-19 patients.

详细描述

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) which defined coronavirus disease 2019 (COVID-19) has prompted innumerable alterations in practice of anesthesiology. The nature of the association between COVID-19 and pregnancy outcomes remains unclear, and meta-analyses involving patients with COVID-19 who are pregnant are limited. A 2020 systematic review suggested that people who are pregnant did not have an increased risk of SARS-CoV-2 infection or symptomatic COVID19, but they were at risk of severe COVID-19 compared with those who were not. But unlike previous viral pandemics, COVID-19 incidence, prognosis and maternal and neonatal outcomes do not appear to be worse in pregnant women compared to that general population.

All of the potential complications of COVID 19 for pregnant and especially higher rate of aerosol transmission to the healthcare persons The American Society of Regional Anesthesia --- ASRA, the European Society of Regional Anesthesia and Pain Medicine --- ESRA and the European Society of Anesthesiology ---ESA published guidance on employing regional anesthesia for patients with COVID-19.

With regional anesthesia the risk of person-to-person transmission, which is 6,6 times higher during the respiratory procedures performed in general anesthesia getting minimalized.

In cesarean section for pregnant women with COVID-19 infection, all the questions for if the spinal anesthesia was safe and efficient in achieving satisfactory obstetrical anaesthesia? At the beginning of the pandemic in a retrospective analysis Chen et al reported that higher rate of hypotension after neuraxial blocks. After this study some questions about safety of the regional anesthesia appeared in the minds.

However, the effects of SARS-CoV-2 infection on hemodynamics of pregnancies who underwent neuraxial anesthesia for cesarean delivery are still unclear. In this study we retrospectively evaluated 249 COVID-19 patients in one center hospital in case the hypotension is the risk for the neuraxial block safety and if so, what we did to treat them?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • SARS-CoV-2 nucleic acid test positive COVID-19 all ASA Physical Status I- II pregnant women who received cesarean delivery under neuraxial anesthesia were eligible for inclusion in the study.

排除标准

  • 未提供

结局指标

主要结局

hypotension

时间窗: From the time of local anesthetic injection to subarachnoid space until 15 min after delivery of the newborn.

Systolic Blood Pressure \<80% of baseline or \<90 mmHg.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aygun cuhadar

anesthesiology and reanimation specialist, MD, primer investigator

Ankara City Hospital Bilkent

研究点 (1)

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