Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04548973
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fetal or Neonatal Effect of Damage to Placenta From Caesarean Section Drug: Esketamine Drug: Normal saline Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Esketamine

Arm Intervention/treatment
Experimental: 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
Drug: Esketamine
Esketamine

Placebo Comparator: Control Group
At the beginning of the operation, 2ml normal saline was given intravenously
Drug: Normal saline
2ml normal saline




Primary Outcome Measures :
  1. visual analog pain score (VAS), and sedation score (Ramsay) [ Time Frame: At the beginning of the operation, before anaesthesia, at the end of the operation, and 1 hour after the operation ]
    visual analog pain score (VAS), and sedation score (Ramsay)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   parturient
Accepts Healthy Volunteers:   No
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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548973


Locations
Layout table for location information
China, Zhejiang
Women's Hospital School of Medicine Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Xinzhong Chen, PhD    13575738058    chenxinz@zju.edu.cn   
Sponsors and Collaborators
Women's Hospital School Of Medicine Zhejiang University
Layout table for additonal information
Responsible Party: Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT04548973    
Other Study ID Numbers: MZK20200831
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Women's Hospital School Of Medicine Zhejiang University:
Esketamine, cesarean section, parturient, placental transfer
Additional relevant MeSH terms:
Layout table for MeSH terms
Esketamine
Antidepressive Agents
Psychotropic Drugs