Spinal Ropivacaine for Cesarean Delivery: A Comparison of Commonly Hyperbaric and Marginally Hyperbaric Solutions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- The maximum cephalad sensory block level
研究概览
简要总结
BACKGROUND: One previous study has confirmed that the marginally hyperbaric solutions of bupivacaine can maintain good quality of anesthesia and get a more steadily hemodynamic status than commonly hyperbaric solutions, some authors confirmed the plain ropivacaine for cesarean section have a higher failure rate and commonly hyperbaric solutions of ropivacaine have a higher incidence of side reaction. It is unclear what the efficacy of spinal marginally hyperbaric ropivacaine for elective cesarean delivery.We hypothesized that the marginally hyperbaric ropivacaine will get a similar efficacy to commonly hyperbaric solutions but a more steadily hemodynamic status.
OBJECTIVE In this prospective, randomized, double-blinded study, Investigator will compare the clinical efficacy and adverse effect of spinal anesthesia with commonly hyperbaric and marginally hyperbaric ropivacaine for elective cesarean delivery.
Main outcome measures: The maximum cephalad sensory block level; the change of continuous cerebral oxygen desaturation (ScO2) over time; the incidence of hypotension and nausea and vomiting; the change of invasive arterial pressure; the consumption of ephedrine; the incidence of shivering; the onset time to T8 dermatome; the quality of anesthesia (efficacy of motor block and sensory block)
详细描述
INTRODUCTION:
One previous study has confirmed that the marginally hyperbaric solutions of bupivacaine can maintain good quality of anesthesia and get a more steadily hemodynamic status than commonly hyperbaric solutions, some authors confirmed the plain ropivacaine for cesarean section have a higher failure rate and commonly hyperbaric solutions of ropivacaine have a higher incidence of side reaction such as hypotension. It is unclear what the efficacy of spinal marginally hyperbaric ropivacaine for elective cesarean delivery.The investigator of this study hypothesized that the marginally hyperbaric ropivacaine would get a similar efficacy to commonly hyperbaric solutions but a more steadily hemodynamic status.In this prospective, randomized, double-blinded study, Investigator will compare the clinical efficacy and adverse effect of spinal anesthesia with commonly hyperbaric and marginally hyperbaric ropivacaine for elective cesarean delivery.
Ethical approval for this clinical trial (Ethical Committee No.) was provided by the Ethics Committee of Qilu Hospital of Shandong University (Qingdao), Qingdao, China on 1 February 2016. Informed written consent will be obtained from all patients. Investigator expected to recruit 120 Pregnant women who will scheduled for elective cesarean section and meet the inclusion criteria.
A computer-generated random number sequence will be used for group allocation. To ensure the study will be double blinded, the anesthesiologist who will administer the anesthesia will take no other part in the study, whilst another anesthesiologist blind to the allocation will collected intraoperative and postoperative data. The patients would be unaware of the treatment allocation. Women will be randomised into two groups: the commonly hyperbaric group (CH) will receive ropivacaine solution with 8.3% glucose; group marginally hyperbaric group (MH) will receive ropivacaine solution with 0.83% glucose; Density will be determined by using a digital density meter (DMA4500M; Anton Paar GmbH, Graz, Austria) at 37°C.Fifteen minutes prior to administration of anesthesia, the ropivacaine solution will be prepared by one nurse who is blind to the patient allocation.Commomly hyperbaric ropivacaine solutions will be made of 0.75% ropivacaine + 50% glucose + isotonic saline and Marginally hyperbaric solutions will be made of 0.75% ropivacaine +5% glucose + isotonic saline. The doses of ropivacaine and the volume of spinal solution will be same and only the density of the solution will be different.
When the patient arrived at the operating room, an IV cannula will be inserted in one forearm. Standard monitoring with electrocardiography and pulse oximetry and cerebral oxygen saturation(ScO2) and invasive blood pressure (IBP) will be attached.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who were scheduled for elective caesarean section and met the criteria for the American Society of Anesthesiologists (ASA) physical status classes 1 to 2 were enrolled in this study. Inclusion criteria were age between 20 and 42 years, height between 160 and 180 cm.
排除标准
- •They had dysfunctional coagulation; had pregnancy-induced hypertension; or had infection around the anesthesia puncture site; or multiple pregnancies, suspected fetal abnormality, and if the gestational age of the infant was less than 36 weeks.
结局指标
主要结局
The maximum cephalad sensory block level
时间窗: During 50 min post spinal injection
The highest cephalad sensory block level is determined by pinprick along both sides of the midclavicular line.
次要结局
- The incidence of hypotension(During 50 min post spinal injection)
- The change rate of invasive arterial pressure(During 15 min post spinal injection)