Randomized Clinical Trial of the Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- compare the success rate of external cephalic version
研究概览
简要总结
External Cephalic Version (ECV) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. Its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. ECV is an effective technique to reduce the rate of cesarean sections and is recommended by the Spanish Society of Obstetrics and Gynecology (SEGO) and the World Health Organization (WHO) Cesarean Section Working Group. The WHO aims to reduce interventionism in childbirth globally and implement non-clinical measures to reduce the rate of unnecessary cesarean sections.
Despite Propofol is a sedative agent commonly used by anesthesiologist in countless ambulatory procedures in obstetric anaesthesia, it has been little studied in ECV, and its effect has not been compared with other commonly used agents such as remifentanil or spinal analgesia. The Obstetric Anesthesiology Section of the Spanish Society of Anesthesiology and Resuscitation recommends the use of locoregional analgesia in ECV.
详细描述
This project involves a randomized clinical trial to compare the effect of sedation with propofol versus spinal analgesia in ECV. Therefore, the objectives of this study are:
- To compare the effect of sedation with Propofol on the success rate of ECV compared to spinal analgesia.
- To compare the effect of sedation with Propofol on the rate of complications of ECV compared to spinal analgesia.
- To compare the effect of sedation with Propofol on the length of hospital stay of ECV compared to spinal analgesia.
Locoregional analgesia requires a longer hospital stay than sedation with Propofol and may mask an early diagnosis of complications after ECV, such as placental abruption, which is identified in the initial stages by intense abdominal pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation.
- •Older than 18 years.
- •Non-cephalic presentation.
- •Desire to attempt a vaginal birth.
- •Normal blood count and coagulation prior to the intervention
排除标准
- •Age under 18 years old.
- •Multiple gestation.
- •Cephalic presentation.
- •Risk of fetal compromise.
- •Unexplained active bleeding.
- •Absolute contraindication for vaginal delivery (Placenta Previa)
- •2 or more previous cesarean sections.
- •Previous myomectomy with entry into the uterine cavity
- •Maternal fever.
- •Thrombocytopenia (<85,000 platelets).
- •Maternal spinal anomaly.
- •Intolerance or allergy to Propofol or any of its components.
- •Intolerance or allergy to bupivacaine or any of its components.
- •Contraindication for intrathecal sedation or analgesia
研究组 & 干预措施
Sedation with propofol
Atropine 0.4 mg intravenous bolus and intravenous propofol will be administered through a continuous infusion with a target plasma concentration between 4-6 micrograms/mL maintaining a BIS between 65-75, following the protocol used by Sánchez-Romero J et al. (doi:10.3390/jcm11030489). For this, an intravenous infusion pump (Agilia SP TIVA ES, Fresenius Kabi AG, Bad Homburg, Germany) will be used. After the administration of propofol, a period of 3 minutes will be waited before starting the procedure to ensure the target plasma concentration.
干预措施: Sedation with propofol (Drug)
bupivacaine
A combined spinal-epidural anesthesia technique will be performed with a spinal dose of 5-7.5 mg of hyperbaric bupivacaine and 20 μg of intrathecal fentanyl, along with the placement of an epidural catheter, following the protocol used by Brogly N et al. in "Protocols of the Obstetric Anesthesia Section of SEDAR, 2021". After the administration of epidural anesthesia, a period of 3 minutes will be waited before starting the procedure to ensure effective anesthesia.
干预措施: Spinal analgesia with bupivacaine (Drug)
结局指标
主要结局
compare the success rate of external cephalic version
时间窗: Up to 24 months.
Number of external cephalic version when Propofol is used as a sedative agent or spinal analgesia.
次要结局
- ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia.(Up to 24 months.)
- rate of nausea or vomiting when using Propofol as a sedative agent or spinal analgesia in ECV.(Up to 24 months)
- angle of progression of fetal presentation as a predictor of ECV success.(Up to 24 months)
- angle of progression of fetal presentation as a predictor of complications of ECV.(Up to 24 months)
- degree of tissue oxygenation of the placenta during ECV by analyzing a pilot sample with infrared spectroscopy (NIRS)(Up to 24 months)
- rate of emergency cesarean sections in the first 24 hours after the procedure when using Propofol as a sedative agent or spinal analgesia in ECV.(Up to 24 months)
- rate of clinically relevant hypotension (SBP <90 mmHg or a 20% decrease from baseline SBP) when using Propofol as a sedative agent or spinal analgesia in ECV(Up to 24 months)
- postprocedural pain when Propofol is used as a sedative agent or spinal analgesia in ECV(Up to 24 months)