Fetal or Neonatal Effect of Damage to Placenta From Caesarean Section Clinical Trial
Official title:
A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During
Verified date | January 2022 |
Source | Women's Hospital School Of Medicine Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | 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 - |
Country | Name | City | State |
---|---|---|---|
China | Women's Hospital School of Medicine Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Women's Hospital School Of Medicine Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | visual analog pain score (VAS), and sedation score (Ramsay) | 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 |