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

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

Sponsors

Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Source Women's Hospital School Of Medicine Zhejiang University
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.

Overall Status Not yet recruiting
Start Date January 1, 2021
Completion Date December 31, 2021
Primary Completion Date December 31, 2021
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
visual analog pain score (VAS), and sedation score (Ramsay) At the beginning of the operation, before anaesthesia, at the end of the operation, and 1 hour after the operation
Enrollment 600
Condition
Intervention

Intervention Type: Drug

Intervention Name: Esketamine

Description: Esketamine

Arm Group Label: Esketamine Group

Intervention Type: Drug

Intervention Name: Normal saline

Description: 2ml normal saline

Arm Group Label: Control Group

Eligibility

Criteria:

Inclusion Criteria:Women who had no preoperatie electrolyte disturbance and immunoendocrine disease and who had not recently receied cardiovascular nonsteroidal anti-inflammatory drugs, hormone drugs or antipsychotic drugs -

Exclusion Criteria:Parturient women with central nervous system disease, liver disease, renal dysfunction, cardiopulmonary dysfunction, diabetes, severe hypovolemia, preeclampsia and eclampsia

-

Gender: Female

Gender Based: Yes

Gender Description: parturient

Minimum Age: 20 Years

Maximum Age: 40 Years

Healthy Volunteers: No

Verification Date

August 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Esketamine Group

Type: Experimental

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

Label: Control Group

Type: Placebo Comparator

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

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov