Effect and Placental Transfer of Dexmedetomidine During Caesarean Section Under Epidural Anaesthesia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Systolic blood pressure of Dexmedetomidine in Epidural Anaesthesia
研究概览
简要总结
Current cesarean section often chooses spinal anesthesia. And in order to avoid the impact of drugs on the fetus, before the delivery, anesthesiologist generally don't use sedative or analgesic drugs. However, the majority of puerperas would appear nervous, anxiety, fear and other psychological reactions in cesarean section. Although the placental transfer and the foetal metabolism of dexmedetomidine have been reported and the result show no adverse effects on neonates, but the placental transfer of dexmedetomidine in intravertebral anesthesia area was lack of systematical research. This study intends to use of dexmedetomidine in the cesarean section under epidural anesthesia and investigate its effects on the parturients' haemodynamics and the neonates' placental transfer and metabolism.
详细描述
Current cesarean section in domestic and overseas often chooses spinal anesthesia. And in order to avoid the impact of drugs on the fetus, before the delivery, anesthesiologist generally don't use sedative or analgesic drugs. However, the majority of puerperas would appear nervous, anxiety, fear and other psychological reactions in cesarean section, and thus produced a series of stress reactions that not only cause the hemodynamic fluctuating in anesthesia and operation, but also lead to different degrees of personality and behavior changed. It causes serious injury to physical and mental health of patients. Dexmedetomidine is a highly selective α2 receptors agonist (α2-AR) ，it has sedation, analgesia, antisympathetic pharmacological effects and unique "conscious sedation" without respiratory depression. At present, dexmedetomidine has been widely used in patients in clinics and clinical anesthesia, it has been hailed as an"dvocate medicine in modern comfortable anesthesia."Experiments in animals have shown that dexmedetomidine had no adverse effects on pregnant rats. In addition, Dexmedetomidine has successful application in preterm infants, infants and children anesthesia, also has a few for caesarean patients sedation reports. Although the placental transfer and the foetal metabolism of dexmedetomidine have been reported and the result show no adverse effects on neonates, but the placental transfer of dexmedetomidine in intravertebral anesthesia area was lack of systematical research.
The safety of the use of dexmedetomidine on neonatal outcome is a very important issue. Experimental study on acute exposure of rats to dexmedetomidine at the anticipated delivery time recorded absence of any adverse effects on perinatal morphology of pups, their birth weight, crown-rump length, physical growth and postnatal behavioural performances. Others studied the transfer of clonidine and dexmedetomidine across the isolated perfused human placenta. Dexmedetomidine disappeared faster than clonidine from the maternal circulation, while even less dexmedetomidine was transported into the fetal circulation. This was due to its greater placental tissue retention, the basis for which probably is the higher lipophilicity of dexmedetomidine.
Umbilical cord blood gas analysis of umbilical vein and umbilical artery in this study was similar to the results of previous studies . The partial oxygen pressure (PO2) of the arterial blood gas in the umbilical vein was not significantly affected to the oxygen supply of the newborn infants. On the other hand, the umbilical arterial blood gas was the most reliable indicator of the oxygenation index and acid-base status of the fetus. Previous studies have indicated that the relationship between hydrogen ion concentration(PH), base excess（BE） and neonatal asphyxia was relatively large, and it was positively related to growth.
Previous research of in vitro placental perfusion indicated that the transfer rate of dexmedetomidine through the placenta to foetus was 0.77, and the other study indicated that the rate of placental transfer of dexmedetomidine in cesarean section operation under general anesthesia was 0.76. It's indicated that dexmedetomidine can also easily pass through the placental barrier like other anaesthetic drugs. However, the placental transfer rate of dexmedetomidine is much lower than that of clonidine(0.85) and that of remifentanil(0.88), which may be caused by dexmedetomidine being more fat-soluble and easier to be retained in the placenta.
Recently, there is a published interested case report about the successful use of dexmedetomidine 1 µg/kg followed with 1 µg/kg/h for 10 minutes before cesarean delivery to facilitate awake fiberoptic endotracheal intubation patient with spinal muscular atrophy type III with provided adequate sedation, without respiratory compromise. Although pharmacokinetic data cannot be determined, this case confirms existing in vitro data that dexmedetomidine has significant placental transfer. Nevertheless, serious neonatal effects were not detected. Similarly, others used, i.v. dexmedetomidine successfully as an adjunct to opioid-based PCA and general anesthesia for the respective provision of labor analgesia and cesarean delivery anesthesia in a parturient with a tethered spinal cord, with favourable maternal and neonatal outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •40 cases of full-term puerperas with single baby ASA I or II, aged 23 to 41 years old, weighing 61-92 kg, without spinal canal puncture contraindication and scheduled for caesarean section under epidural anesthesia were selected for this study.
排除标准
- •women with a history of cardiac, liver, or kidney diseases;
- •women with allergy to amide local anesthetics;
- •women with epilepsy;
- •those taking cardiovascular medications;
- •those with pregnancy-induced hypertension;
- •women with evidence of intrauterine growth restriction or fetal compromise.
研究组 & 干预措施
Dexmedetomidine 0.5 µg/kg/h
Solution containing 5 µg/mL of dexmedetomidine was continuously infused by 0.5 μg/kg in 10 min, followed with 0.1 ml/kg/hr continuous infusion until the closure of the abdominal.
干预措施: Dexmedetomidine (Drug)
Placebo
The placebo group (n = 20) will pumped in the same volume of saline 0.9% as calculated by patients' weight in 10 min, then will receive an i.v. infusion of 0.1 mL/kg/h saline 0.9%, until the closure of the abdominal.
干预措施: Placebo (Drug)
结局指标
主要结局
Systolic blood pressure of Dexmedetomidine in Epidural Anaesthesia
时间窗: before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation
identifying the effects of 0.5 µg/kg/h dexmedetomidine for systolic blood pressure changes.
Heart rate of Dexmedetomidine in Epidural Anaesthesia
时间窗: before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation
identifying the effects of 0.5 µg/kg/h dexmedetomidine for heart rate changes.
Saturation of pulse oxygen of Dexmedetomidine in Epidural Anaesthesia
时间窗: before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation
identifying the effects of 0.5 µg/kg/h dexmedetomidine for saturation of pulse oxygen changes.
Diastolic blood pressure of Dexmedetomidine in Epidural Anaesthesia
时间窗: before anesthesia, infused 10 min, at the delivery of the baby, at the end of the operation
identifying the effects of 0.5 µg/kg/h dexmedetomidine for diastolic blood pressure changes.
次要结局
- sedation of Dexmedetomidine in Epidural(before anesthesia, skin incision and 10min after delivery)
- adverse events(intraoperative and in 48 hours after surgery)
- plasma concentrations of dexmedetomidine(at the delivery of the baby)
- Apgar score related to treatment(1 and 5 minute after delivery)
- Blood gas analysis(at the delivery of the baby)
- Placental Transfer of Dexmedetomidine in Epidural(at the delivery of the baby)
研究者
Cunming Liu
Chief officer
The First Affiliated Hospital with Nanjing Medical University