visual analog pain score (VAS), and sedation score (Ramsay)
A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During Cesarean Section
Condition or Disease
- Fetal or Neonatal Effect of Damage to Placenta From Caesarean Section
|Study results:||No Results Available|
|Age:||20 Years to 40 Years|
Clinical Trial Dates
|Start date:||Jan 01, 2021||ACTUAL|
|Primary Completion:||Dec 31, 2022||ESTIMATED|
|Completion Date:||Dec 31, 2022||ESTIMATED|
|Study First Posted:||Sep 16, 2020||ACTUAL|
|Last Updated:||Jan 25, 2022|
Sponsors / Collaborators
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.
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
At the beginning of the operation, 2ml normal saline was given intravenously
Exclusion Criteria:Parturient women with central nervous system disease, liver disease, renal dysfunction, cardiopulmonary dysfunction, diabetes, severe hypovolemia, preeclampsia and eclampsia
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