Use of Ultiva ® Associated With Xylocaine ® in the Procedures of Feticide: A Phase III Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- The deadline of obtaining the asystole
研究概览
简要总结
The feticide is a legal and ethical obligation during a termination of pregnancy after 22 weeks' gestation. This method raise concerns about the fetal pain, maternal complications and the fetopathologic analysis. There are few studies on the subject. Investigators want to evaluate a drug in order to facilitate this method technically and emotionally challenging. They want to achieve a quick fetal asystole, a fetal analgesia, a maternal security and a optimal fetopathologic analysis. A drug, remifentanil Ultiva®, seems could meet its properties, it is a powerful morphine. A phase 2 clinical trial has assessed the feasibility, efficacy and safety of Ultiva®. They had not been able to prove bradycardia or lethal effect of Ultiva injected alone but the feasibility and safety were good.
Investigators want to set up a randomized clinical trial with 2 arms : Ultiva® and lidocaine versus sufentanil and lidocaine (standard protocol), it is a bicentric study. The primary outcome is the interval between the vascular injection of lidocaine and fetal asystole. The secondary outcomes are the success rate of method, the number of puncture of the umbilical cord, the maternal side effects and the quality of fetopathologic analysis.
The previous observational study showed a median interval of 2,3 minutes and a success rate of 55% (lower interval to 2 minutes). From the results they calculate a necessary inclusions to 66 patients.
They believe that the bradycardia property of Ultiva® allow a potentiation of the efficacy of lidocaine. If the results are satisfactory, the use of Ultiva® can be generalized to other fetal medicine team.
详细描述
The intervention will take place, as in the framework of usual care, obstetric block after achievement of maternal locoregional anesthesia peri-rachianesthesia, skin disinfection and sterile field. The gesture will be performed by an experienced obstetrician under ultrasound guidance. Anesthetist-resuscitator is present in the obstetric block. Peri-rachianesthesia is performed by the initial injection of 2.5mg of hyperbaric bupivacaine associated with 5 gamma of Sufentanil and 0.5ml of physiological saline.
Inclusion in one of two arms is defined after randomization in single blind:
Arm 1 (Sufentanil + Lidocaïne) or Arm 2 (Ultiva® + Lidocaïne) For patients randomized in the arm 1, we will realize the reference protocol, as in the current practice, by injecting Sufentanil intra-cordally at the posology of 1,5 μg / kg of estimated fetal weight, then Lidocaïne 1% in bolus of 10 ml (10 mg / ml).
If 2 minutes after the start of the injection of Lidocaïne, there is no obtaining of fetal asystole, we will inject 100 mg of Lidocaïne 1% into a 10 ml bolus. In case of failure of the procedure, we will inject 10ml of KCL 10% intra-cordial if the cord is still accessible, if not intra-cardiac.
For patients randomized to arm 2, we will intracenally inject Ultiva® 30 μg and Lidocaïne 1% into 10 ml bolus (10 mg / ml).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Age > = 18 years
- •Patient having received an authorization of medical termination of pregnancy beyond 22 weeks of amenorrhea by the Multidisciplinary Centers of Prenatal Diagnosis of Montpellier or Nimes
- •Patient member or beneficiary of a national insurance scheme
- •Patient capable of understanding the nature, the purpose and the methodology of the trial
- •Patient having given an informed consent signed before the inclusion in the trial
排除标准
- •Patient presenting a selective or total feticide in the cases of multiple pregnancies (the first preferential way in these cases is intracardiac, moreover the act risks to be complicated by the active movements of the other foetus)
- •Major Patient protected by the law (guardianship, curators, or under protection of justice)
- •Patient deprived of freedom by court or administrative order
研究组 & 干预措施
Arm 1: Sufentanil + Lidocaïne
For patients randomized to arm 1, as in the current practice, we will inject Sufentanil intra-cordially at the dose of 1.5 μg / kg of the estimated fetal weight, then the Lidocaïne 1% bolus of 10 ml (10 mg / ml).
If 2 minutes after the start of the injection of Lidocaïne, there is no obtaining of fetal asystole, we will inject 100mg of Lidocaïne 1% in bolus of 10 ml. In the event of failure of the procedure, we will inject 10ml of KCL 10% intra-cordial if the cord is always accessible, if not intra-cardiac.
干预措施: Sufentanil + Lidocaïne (Drug)
Arm 2: Remifentanil + Lidocaïne
For patients randomized to arm 2, we will inject 30 μg of intravenous Remifentanil (Ultiva®) followed by Xylocaine 1% in a 10 ml bolus (10 mg / ml).
If 2 minutes after the start of the injection of Lidocaïne, there is no obtaining of asystole, we will inject 100 mg of Lidocaïne 1% in bolus of 10 ml. In case of failure of the procedure, we will inject 10 ml of KCL 10% intra-cordial if the cord is still accessible, if not intra-cardiac.
干预措施: Remifentanil + Lidocaïne (Drug)
结局指标
主要结局
The deadline of obtaining the asystole
时间窗: up to 5 minutes
The deadline of obtaining the asystole after the beginning of the injection of the ULTIVA associated with Xylocaine versus the reference protocol Sufentanil and Xylocaine
次要结局
- The success rate of the procedure of foeticide(within 2 minutes after injection of Lidocaïne and persistent during at least 1 minute)
- The number of new punction(s) of the cordon(1 day)
- Number of side effects(1 day)
- The quality of tissues (the fetopathologic analysis)(1 day)