A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During Cesarean Section

Women's Hospital School Of Medicine Zhejiang University

Status and phase: Completed; Phase 4

Conditions: Fetal or Neonatal Effect of Damage to Placenta From Caesarean Section

Treatments: Drug: Normal saline; Drug: Esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04548973

MZK20200831

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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600 participants in 2 patient groups, including a placebo group

Esketamine Group

Experimental group

Description:

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

Treatment:

Drug: Esketamine

Control Group

Placebo Comparator group

Description:

At the beginning of the operation, 2ml normal saline was given intravenously

Treatment:

Drug: Normal saline