A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Maternal sedation level
研究概览
简要总结
This study proposed applying intravenous Esketamine to cesarean section in parturient, detecting the plasma concentration of Esketamine in maternal blood, neonatal umbilical venous blood and umbilical arterial blood when the baby is delivered ketamine blood drug concentration, observing vital signs, adverse visual analog pain score (VAS), and sedation score (Ramsay) in parturient, neonatal Apgar score 1, 5 to 10 minutes after birth, the umbilical arterial blood gas and neurobehavioral scores (NBNA) 2, 24 hours after the birth. This study aims to address placental transfer, metabolism and analgesic and sedative effects in neonates and parturients of Esketamine so as to explore the feasibility, efficacy and safety of Esketamine as adjuvant medication for cesarean section.
详细描述
- case selection: A total of 600 patients (American Society of Anesthesiologists (ASA) grade I-II, aged 20-40 years,BMI 18.5-27) who underwent elective cesarean section were selected.
- anesthesia methods: All patients were not given preoperative medication. After entering the operating room, peripheral venous connection was opened. Mindray multifunctional vital sign monitor continuously monitored electrocardiogram (ECG), heart rate (HR), pulse oxygen saturation (SpO2), systolic blood pressure (SBP), diastolic blood pressure (DBP) and Mean arterial pressure (MAP). After 5 minutes of waiting for patients with no obvious discomfort, 0.75% of ropivacaine was given 10ml before catheterization, and 0.75% of ropivacaine 3-5ml per hour maintained anesthesia
- Grouping methods: A random number table was used to divide the patients into two groups with 300 patients in each group: The Esketamine group (group A) and the control group (group B) Esketamine group (Group A): at the beginning of the operation, 0.25mg/kg(2ml) Esketamine was administered intravenously as an adjuvant sedation and analgesia;Control group (Group B): 2ml normal saline was given intravenously at the beginning of the operation;
- Observation items and methods 4.1 Forty patients were randomly selected from the Estroketamine group (group A) to detect the serum concentrations of Esketamine in umbilical vein blood and umbilical artery blood of neonates during fetal delivery.
4.2 maternal hemodynamic indexes such as heart rate (HR), mean arterial pressure (MAP) and respiratory mechanics indexes such as pulse oxygen saturation (SpO2) and shout at the end of the co2 partial pressure (PaCO2) are measured before anesthesia surgery at the beginning of the fetal childbirth at the end of the operation and operation after 1 hour when recording and compare the two groups of 4.3 maternal visual analog pain score (VAS) and sedation scores (Ramsay) and the time from uterine incision to fetal childbirth are measured before anesthesia surgery at the beginning of the fetal childbirthAt the end of the operation and operation after 1 hour record and compare the two groups of 4.4 respiratory system complications within 72 h in pregnant women (hypotension sinus bradycardia nausea and vomiting respiratory depression) are record.
4.5 Apgar score 1, 5, 10 minutes after birth, umbilical arterial blood gas and neurobehavioral scores (NBNA) 2 and 24 hours after the birth are record.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •full-term single pregnancy
- •had regular prenatal examination
- •scheduled for elective cesarean delivery with epidural anesthesia
排除标准
- •body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or greater
- •previous mental illness, central nervous system disease, liver disease, abnormal kidney function, abnormal heart and lung function, diabetes, or American Society of Anesthesiologists (ASA) classification III or above
- •severe obstetric complications, such as preeclampsia and eclampsia, pregnancy-induced hypertension, placenta previa, or placental abruption
- •stillbirth or neonatal malformation
- •contraindications to epidural anesthesia, including abnormal coagulation function, anticoagulant therapy, severe hypovolemia, or hemodynamic instability
研究组 & 干预措施
Esketamine Group
At the beginning of the operation, 0.25mg/kg ketamine was administered intravenously, and normal saline was diluted to 2mL to assist sedation and analgesia
干预措施: Esketamine (Drug)
Control Group
At the beginning of the operation, 2ml normal saline was given intravenously
干预措施: Normal saline (Drug)
结局指标
主要结局
Maternal sedation level
时间窗: immediately after fetal delivery
Maternal sedation level was assessed with Ramsay Sedation Scale (with 1 indicating restless; 2, completely awake, quiet, and cooperative; 3, drowsy but responding to verbal commands; 4, lightly asleep but responding to touch or pain; 5, asleep but slowly responding to touch or pain; and 6, deeply asleep and does not respond)
Maternal pain intensity
时间窗: immediately after fetal delivery
Pain intensity was assessed with the numeric rating scale (NRS; an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain)
次要结局
- systolic blood pressure, diastolic blood pressure, and mean blood pressure(before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery)
- Apgar score of newborn(at 1 minute and 5 minute after birth)
- postnatal umbilical vein blood gas pH value(Results of umbilical arterial blood gas analysis after birth)
- Esketamine concentrations in maternal arterial blood and neonatal umbilical arterial(Immediately after fetal delivery)
- Maternal pain intensity at other timepoints(before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration,)
- Maternal sedation level at other timepoints(before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration,)
- maternal heart rate(before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery)
- pulse oxygen saturation(before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery)