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临床试验/NCT02111421
NCT02111421已完成4 期

Optimal Dose of Dexmedetomidine Sedation Following Spinal Anesthesia: Postpartum Versus Nonpregnant Women

Guangzhou General Hospital of Guangzhou Military Command1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月最近更新:
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
60
试验地点
1
主要终点
The assessment of sedation

研究概览

简要总结

Currently, spinal anesthesia is most commonly used for cesarean section.But spinal anesthesia can not block the visceral vagus nerve, and the patients are prone to nausea, vomiting, chest tightness or other discomfort when the uterus is stretched .For parturients who have poor uterine contractions and are bleeding larger, obstetricians often use oxytocin to strengthen the contraction of the uterine,which also would increase the parturients' discomfort.Anesthesiologists often intravenous sedative hypnotics (eg.propofol or midazolam) to alleviate the fear of the parturients after the baby is delivered.One of the side effects of propofol or midazolam is that they would lead to the respiratory depression.For the poor respiratory reserve of the parturients, functional residual capacity(FRC) of this group could be reduced by up to 20%, and the oxygen consumption was also increased.The SPO2 could decline quickly intraoperatively.Dexmedetomidine is a novel , highly selective α2 adrenergic receptor agonists , and its selectivity for α2 receptor is 1600 times higher than α1.It also could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects.Because of its minimal impact on the respiratory , it could safely and effectively used to sedate patients undergoing cesarean section.But the change of endocrine system and hemodynamic of the parturients may affect the pharmacokinetics and pharmacodynamics of some anesthetic drugs.Currently studies have demonstrated the increased sensitivity of some anesthetic drug in parturients, such as lidocaine and isoflurane.The study is aim to explore the optimal dexmedetomidine dose to produce suitable sedation in parturients ,and compared with norman nonpregnant women.

详细描述

Parturients undergo cesarean section and normal nonpregnant women undergo lower abdominal surgery were scheduled . All patients accepted spinal anesthesia first.And then an dose of dexmedetomidine would be performed after umbilical cord was clapped in the parturients and in non-pregnant women group the dose of dexmedetomidine would be performed after the spinal anesthesia was conducted.Initial doses was 1.0μg/kg,with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points. Each patient's sedation state was assessed using the modified observer's assessment of awareness /sedation (OAA/S) scale every 5 min after starting the dexmedetomidine infusion for 30 min. Adequate sedation was defined as an OAA/S≤3 at any assessment time point during the 30 min

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA Ⅰ ~ Ⅱ women undergoing cesarean surgery under spinal anesthesia
  • ASA Ⅰ ~ Ⅱ nonpregnancy women undergoing lower abdominal surgery under spinal anesthesia
  • Written informed consent from the patient or the relatives of the participating patient
  • nonpregnancy women BMI:18~25 kg/m2 , parturients BMI <35kg/m2

排除标准

  • Mental illness can not match
  • Spinal anesthesia contraindicated
  • People who have Slow-type arrhythmias
  • People who were language or hearing impaired
  • Sensory block reached to T6 or higher.
  • People who had lung infection or sleep apnea syndrome.
  • Chronic renal failure
  • Alcohol or drug abuse
  • Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

研究组 & 干预措施

parturients

Experimental

Parturients after the umbilical cord was clapped in cesarean section were accepted an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points.

干预措施: Dexmedetomidine 01 (Drug)

nonpregnant women

Experimental

Nonpregnant women were accepted an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points.

干预措施: Dexmetomidine 02 (Drug)

结局指标

主要结局

The assessment of sedation

时间窗: every 5 min after starting the dexmedetomidine infusion for 30 min

The aim of our study is to define the median effective sedative dose (ED50) of dexmedetomidine for providing adequate sedation in cesarean surgery,using the Dixon up-and-down method. Adequate sedation was defined as an OAA/S≤3 at any assessment time point during the 30 min after dexmedetomidine infusion.

次要结局

  • comparision of ED50(every 5 min after starting the dexmedetomidine infusion for 30 min)

研究者

发起方
Guangzhou General Hospital of Guangzhou Military Command
申办方类型
Other
责任方
Principal Investigator
主要研究者

bo xu

associate chief physician

Guangzhou General Hospital of Guangzhou Military Command

研究点 (1)

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