Clinical trial NCT04548973: A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During Cesarean Section
Official title: A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fetal or Neonatal Effect of Damage to Placenta From Caesarean Section
Keywords: Esketamine, cesarean section, parturient, placental transfer
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 600
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 1. 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.
2. 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
3. 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;
4. 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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* full-term single pregnancy
* had regular prenatal examination
* scheduled for elective cesarean delivery with epidural anesthesia

Exclusion Criteria:

* 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

Primary outcomes:
measure: Maternal pain intensity
timeFrame: immediately after fetal delivery
measure: Maternal sedation level
timeFrame: immediately after fetal delivery
Secondary outcomes:
measure: Maternal pain intensity at other timepoints
timeFrame: 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,
measure: Maternal sedation level at other timepoints
timeFrame: 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,
measure: systolic blood pressure, diastolic blood pressure, and mean blood pressure
timeFrame: 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
measure: maternal heart rate
timeFrame: 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
measure: pulse oxygen saturation
timeFrame: 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
measure: Apgar score of newborn
timeFrame: at 1 minute and 5 minute after birth
measure: postnatal umbilical vein blood gas pH value
timeFrame: Results of umbilical arterial blood gas analysis after birth
measure: Esketamine concentrations in maternal arterial blood and neonatal umbilical arterial
timeFrame: Immediately after fetal delivery
Other outcomes:
measure: Adverse events including hypotension, hypertension, bradycardia, tachycardia and desaturation
timeFrame: Adverse events were recorded as Frequency of occurrence between the time the patient entered the operating room and the end of surgery
measure: offspring's neurodevelopment
timeFrame: 2 years after birth
measure: Mothers' memories of childbirth
timeFrame: at 2 years after birth
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
Study officials:
References: