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

NCT04548973 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-12-04

No results posted yet for this study

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.

Conditions

  • Fetal or Neonatal Effect of Damage to Placenta From Caesarean Section

Interventions

DRUG

Esketamine

Esketamine

DRUG

Normal saline

2ml normal saline

Sponsors & Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-18
Primary Completion
2022-09-20
Completion
2024-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04548973 on ClinicalTrials.gov