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临床试验/NCT03743870
NCT03743870Unknown不适用

Spinal Anesthesia in Caesarean Section: Comparison Between Levobupivacaine and Hyperbaric Bupivacaine

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
250
试验地点
1
主要终点
Changes in blood pressure measured continuously by the EV1000® platform and the Clearsight® non-invasive system (Edwards Lifesciences) in the two study cohorts

研究概览

简要总结

Spinal anesthesia is a safe technique, widely used and tested in the gynecological field, so as to be considered the first choice technique in cesarean section, which allows to quickly obtain a valid sensor and motor block. Bupivacaine is one of the most widely used drug for obtaining spinal anesthesia in pregnant women undergoing caesarean section. Bupivacaine is a local anesthetic available as a racemic mixture of its two enantiomers, the R (+)- dextrobupivacaine and the S (-) - levobupivacaine, whose clinical use is widely validated. Racemic bupivacaine is available as a simple or hyperbaric solution, the latter being the most commonly used for spinal anesthesia. Levobupivacaine, which is the pure levorotatory enantiomer of racemic bupivacaine, is a slightly hypobaric solution compared to liquor and has shown less heart and nerve toxicity, probably due to its ability to bind proteins more rapidly, and a greater selectivity towards the sensory component compared to Bupivacaine, presents action and effects better predictable. Its baricity would also offer the advantage of providing a less sensitive block to the position.

Hypotension is one of the most common complications of spinal anesthesia and is particularly relevant in caesarean section because, in addition to the adverse effects on the parturient, it can have repercussions on the fetus through a reduction of placental perfusion.

Some studies have showed a similar incidence of hypotension in patients treated with bupivacaine compared to those treated with levobupivacaine, while others assert an equivalence between the two drugs. In most studies, however, a significantly lower incidence of hypotension and a greater hemodynamic stability were reported in pregnant patients undergoing spinal anesthesia by caesarean section with levobupivacaine.

Being both hyperbaric bupivacaine and levobupivacaine routinely used at the "G. Rodolico" Universitary Hospital of Catania for the spinal anesthesia of pregnant women undergoing caesarean section and being their use decided exclusively at discretion of the treating anesthesiologist, in the light of the discrepant data in the literature about the incidence of hypotension with the two drugs, the main objective of this observational study is to evaluate the hemodynamic effects mediated by levobupivacaine on pregnant women subjected to elective cesarean section and to compare them with those mediated by hyperbaric bupivacaine in an historical court of pregnant women subjected to caesarean section in the period between April 2017 and April 2018. The hemodynamic parameters will be monitored in real time with a non-invasive hemodynamic monitoring system (EV1000® platform + Clearsight® system - Edwards LifeSciences), routinely used in the "G. Rodolico" Universitary Hospital of Catania, allowing to obtain greater accuracy and veracity of the results compared to previous studies conducted on such anesthetics.

详细描述

This is a prospective, monocentric, not for-profit, observational study, with historical control group, whose primary objective is the monitoring of changes in the hemodynamic condition, intended as continuous pressure measurements by means of a non-invasive system (EV1000® platform + Clearsight® system - Edwards Lifesciences), of a group of 125 pregnant women who have to undergo spinal anesthesia with Levobupivacaine for elective cesarean section at the "G. Rodolico" Presidium of Azienda Ospedaliero Universitaria "Policlinco-Vittorio Emanuele" of Catania, and to compare them with those detected, with the same non-invasive system, in an historical cohort of 125 patients who underwent spinal anesthesia with Bupivacaine for an elective caesarean section in the period between April 2017 and April 2018.

The study will have an expected duration of one year from the time of its approval.

In the levobupivacaine group, during the preoperative anesthesiological examination, carried out approximately two weeks before the scheduled date of the surgical intervention, informed consent will be acquired and the eligible patients will be enrolled. On this occasion, an ASA class will be assigned and the following data will be collected:

  • personal and general data:

  • date of birth and age

  • current weight

  • weight before pregnancy

  • height

  • information concerning:

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • signature of informed consent
  • age between 18 and 40 years old
  • indication for spinal anesthesia
  • American Society of Anesthesiology (ASA) classification I or II
  • height less than 180 cm
  • weight less than 100 kg
  • absence of spinal deformities

排除标准

  • age under 18 years old or over 40 yers old
  • ASA III or IV
  • contraindications to spinal anesthesia
  • presence of hemodynamically relevant cardiovascular co-morbidities
  • co-morbidities requiring invasive monitoring
  • refusal of pregnant women to sign informed consent
  • refusal of pregnant women to spinal anesthesia
  • spinal deformities in pregnant women
  • known hypersensitivity to the anesthetics used
  • weight over 100 kg
  • height over 180 cm
  • preeclampsia or eclampsia
  • presence of fetal or placental abnormalities such as placenta previa or placental abruption

研究组 & 干预措施

levobupivacaine cohort

125 pregnant patients that will have to undergo spinal anesthesia with Levobupivacaine for elective caesarean section.

干预措施: Levobupivacaine (Drug)

bupivacaine cohort

Historical control group made of 125 patients underwent spinal anesthesia with Bupivacaine for elective cesarean section during the period between April 2017 and April 2018.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Changes in blood pressure measured continuously by the EV1000® platform and the Clearsight® non-invasive system (Edwards Lifesciences) in the two study cohorts

时间窗: From arrival in the operating room until the completion of surgical procedures

次要结局

  • Need for inotropes and / or vasopressor during surgery(At 60 minutes after completion of surgical procedures)
  • Aldrete score evaluation.(At 15 minutes from the beginning of anesthesia)
  • Need for fluids administration during surgery(At 60 minutes after completion of surgical procedures)
  • Level of the sensory block reached(At 30 minutes from the beginning of anesthesia)
  • Incidence of bradycardia during spinal anesthesia(At 60 minutes after completion of surgical procedures)
  • Time in which sensory block occurs(At 60 minutes from the beginning of anesthesia)
  • Incidence of hypotension during spinal anesthesia(At 60 minutes after completion of surgical procedures)
  • Level of sensory block reached(At 60 minutes from the beginning of anesthesia)
  • Level of the motor block reached by modified Bromage scale(At 60 minutes from the beginning of anesthesia)
  • Aldrete's score evaluation(At 60 minutes from the beginning of anesthesia)

研究者

发起方
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmelo Minardi

Principal Investigator

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

研究点 (1)

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