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临床试验/NCT07108881
NCT07108881已完成4 期

Ultrasound Guided Fluid Loading Before Spinal Anesthesia for Cesarean Section in Hypovolemic Parturient: Double-Blind Randomized Controlled Trial

University Tunis El Manar1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2024年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
incidence of post-spinal anesthesia arterial hypotension during surgery

研究概览

简要总结

Perioperative hypotension is a common complication of spinal anesthesia during cesarean sections.

The aim of this study was to evaluate the effectiveness of echoguided correction of hypovolemia through crystalloid preloading on the incidence of arterial hypotension during scheduled cesarean sections under spinal anesthesia.

It was a double-blind, randomized controlled trial study conducted on hypovolemic parturients, scheduled for cesarean section. investigators compared ultrasound guided correction of hypovolemia to a standard care protocol without preloading.

Hypovolemia was defined as a ≥12% increase in the variation of the velocity-time integral of subaortic blood flow during a passive leg raising test.

Preloading was guided by the variation of the velocity-time integral of subaortic blood flow during volume expansion tests.

详细描述

In the literature, numerous studies have compared the different pre-filling and co-filling protocols with different solutes. The majority of them conclude that co-filling is superior to pre-filling when the same type of solute is used. Pre-filling with crystalloids was then abandoned in favor of co-filling with crystalloids It is essential to remember that several invasive or non-invasive means of hemodynamic monitoring have previously been validated in pregnant women The use of invasive tools for assessing blood volume, particularly arterial and central venous catheters, is limited given the brevity of obstetric procedures, the risk of morbidity in awake patients and their high costs. Although non-invasive methods are preferable, some remain imperfect, notably carotid Doppler and bioimpedance devices Transthoracic echocardiography stands out as a particularly reliable and relevant non-invasive tool for assessing cardiac output and blood volume in parturients It allows analysis of the variation of the subaortic velocity time integral (∆ ITV s-a) during the passive leg raise test (LET). It is the only dynamic preload parameter validated in patients during spontaneous ventilation, thus allowing assessment of blood volume.

After reviewing the literature, the investigators found no studies about, exclusively hypovolemic patients, the effect of combining pre-filling with co-filling with crystalloids, monitored by echocardiographic preload-dependence indices, on the incidence of arterial hypotension during elective cesarean sections performed under spinal anesthesia.

In this study, monitoring was performed by transthoracic echocardiography, based on the variation in subaortic TVI following the passive leg raise test and vascular fluid tests.

The objective of this prospective randomized study was to evaluate the efficacy of ultrasound-guided correction of hypovolemia by pre-filling with crystalloids on the incidence of arterial hypotension during elective cesarean sections performed under spinal anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

participant was blinded outcome assessors performed ultrasound to assess volemia but later were not aware of randomization care givers did know about randomization in order to give treatement according to the allocation

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA II score, singleton pregnancy cesarean section

排除标准

  • Spinal anesthesia failure general anesthesia postpartum hemorhage saline solution volume > 1000 ml for preloading echocardiography: difficulties Poor echogenicity

研究组 & 干预措施

group C

Active Comparator

hypovolemic parturient receiving cardiac -ultrasound -VTI guided cristalloid preloading with 1 to 4 fluid challenges of 250 ml each until they reach a normal volemic state before receiving spinal anesthesia

干预措施: C (Drug)

groupT

Placebo Comparator

hypovolemic parturient reiving the standard care ie; they dont receive any preloading but coloading with critalloids with rescue boluses of ephedrine if hypotension happens

干预措施: T (Drug)

结局指标

主要结局

incidence of post-spinal anesthesia arterial hypotension during surgery

时间窗: 60 minutes

The incidence of intraoperative post-spinal hypotension Defined by a drop in blood pressure (BP) of more than 20% of its reference value, or a blood pressure (BP) \< 100 mmHg

次要结局

  • Time to onset of the first episode of arterial hypotension (min)(60 minutes)
  • Duration of hypotensive episode (min)(60 minutes)
  • Depth of hypotension (% fall from baseline value)(60 minutes)
  • Consumption of per-op vasopressors (mg of ephedrine)(60 minutes)
  • Fetal pH at the umbilical cord at birth.(30 minutes)
  • Newborn APGAR score at the first and fifth minute(30 minutes)
  • Variation in intraoperative cardiac output (% drop from baseline)(60 minutes)
  • Volume of cristalloids and colloids infused (ml)(60 minutes)
  • Incidence of maternal bradycardia (%) -(60 minutes)
  • Incidence of intraoperative nausea and vomiting (%)(60 minutess)

研究者

发起方
University Tunis El Manar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ben marzouk Sofiene

principal inverstigator

University Tunis El Manar

研究点 (1)

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