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临床试验/NCT05624671
NCT05624671已完成不适用

Is Elective Caesarean Sections for Predicting Post-spinal Hypotension Role of Overactive Bladder?

Ataturk University1 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
143
试验地点
1
主要终点
Is Elective Caesarean Sections for Predicting Post-spinal Hypotension (reduction of systolic blood pressure(mmHg) after spinal anesthesia) Role of Overactive Bladder?

研究概览

简要总结

It is to predict postspinal hypotension that may develop in patients diagnosed with overactive bladder who will undergo elective cesarean section under spinal-epidural anesthesia.

详细描述

INTRODUCTION

Spinal anesthesia is the most preferred standard anesthesia technique in caesarean sections. After a C-section, hypotension develops in approximately 70% of pregnant women and 33% of nonpregnant women and this situation is generally more severe and sudden in pregnant women. Aortocaval compression and low basal vasomotor tone caused by the Gravid Uterus and sympathetic blockade associated with spinal anesthesia contribute to this sudden onset and deep hypotension. Serious post-spinal hypotension that is not properly treated can increase the risks of maternal and fetal complications. It is important to identify patients at high risk of developing hypotension. Because it will enable us to manage the process more proactively.

Many predictive methods such as thoracic electrical bioimpedance, heart rate (HR) variability, pupillary light reflex analysis, and perfusion index (PI) were used to predict the onset of hypotension. In some studies, it has been shown that hypotension may develop with disruption of the balance between sympathetic and parasympathetic nervous systems in the autonomic nervous system.

The bladder is an organ in which the sympathetic and parasympathetic system works in coordination. For a normal micturition, the balance between the sympathetic and parasympathetic systems should not be disturbed. Overactive bladder (OAB) is a syndrome that includes symptoms such as sudden and severe urination, urge to urinate suddenly, incontinence before reaching the toilet, and frequent urination (≥8 per day). Overactive bladder can be diagnosed based on subjective symptoms instead of urodynamic tests. In our country, the rate is 20% for males, 35.7% for females and 29.3% for both sexes. The main problem here is the balance disturbed between the sympathetic and parasympathetic systems.

Our primary goal in the study is to predict post-spinal hypotension that may develop in patients with a diagnosis of the overactive bladder who will undergo elective cesarean under combined spinal epidural anesthesia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Primigravid
  • •Elective cesarean sections

排除标准

  • •Emergency surgery
  • •Pregnancy-induced hypertension,
  • •Significant systemic disease,
  • •Multiple pregnancy,
  • •Fetal or placental abnormality,
  • •History of hypersensitivity or allergy to drugs to be used in the study,
  • •Morbidly obese (BMI≥40),
  • •Patients for whom neuraxial anesthesia is contraindicated,
  • •Unable or unwilling to participate

研究组 & 干预措施

IS THERE ANY ROLE OF OVERACTIVE BLADDER IN POSTSPINAL HYPOTENSION IN ELECTIVE CAESAREAN SECTIONS?

Other

According to our institution protocol, intravenous (iv) hydration will not be given as preload and afterload and vasopressor infusion will not be initiated before spinal anesthesia. After the skin is prepared sterile and local infiltration with 2% lidocaine is done, from L3-L4 OR L4-L5 range on midline with the 16 gauge Tuohy needle and the loss of resistance technique epidural space is identified and then 26 gauge pencil point needle is passed trough the Touhy and the dura will be drilled. After the cerebrospinal fluid (CSF) is seen the fluid containing 5mg isobaric bupivacaine and 15µg fentanyl will be given in 30 seconds to patients. After the spinal needle is removed, the epidural catheter is placed 3-5 cm in the epidural space through Tuohy, and after the catheter is fixated, the patients will be placed in the supine position by placing a height under their right hip with a 15 ° angle.

干预措施: bupivacaine,fentanyl (Other)

结局指标

主要结局

Is Elective Caesarean Sections for Predicting Post-spinal Hypotension (reduction of systolic blood pressure(mmHg) after spinal anesthesia) Role of Overactive Bladder?

时间窗: Intraoperative period

It is to predict postspinal hypotension (systolic blood pressure below 20% of the basal value) that may develop in patients diagnosed with overactive bladder who will undergo elective cesarean section under spinal-epidural anesthesia.

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

Aysenur Dostbil

Professor Doctor

Ataturk University

研究点 (1)

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