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

NCT04548973 | Completed Phase 4

• 1 other identifier: MZK20200831
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal or Neonatal Effect of Damage to Placenta From Caesarean Section

Keywords

Esketamine, cesarean section, parturient, placental transfer

Outcome Measures

Primary Outcomes (2)

• Maternal pain intensity

  Pain intensity was assessed with the numeric rating scale (NRS; an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain)

  immediately after fetal delivery

• Maternal sedation level

  Maternal sedation level was assessed with Ramsay Sedation Scale (with 1 indicating restless; 2, completely awake, quiet, and cooperative; 3, drowsy but responding to verbal commands; 4, lightly asleep but responding to touch or pain; 5, asleep but slowly responding to touch or pain; and 6, deeply asleep and does not respond)

  immediately after fetal delivery

Secondary Outcomes (8)

• Maternal pain intensity at other timepoints

  before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration,

• Maternal sedation level at other timepoints

  before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration,

• systolic blood pressure, diastolic blood pressure, and mean blood pressure

  before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery

• maternal heart rate

  before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery

• pulse oxygen saturation

  before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery

Other Outcomes (3)

• Adverse events including hypotension, hypertension, bradycardia, tachycardia and desaturation

  Adverse events were recorded as Frequency of occurrence between the time the patient entered the operating room and the end of surgery

• offspring's neurodevelopment

  2 years after birth

• Mothers' memories of childbirth

  at 2 years after birth

Study Arms (2)

Esketamine Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Esketamine DRUG

Esketamine

Esketamine Group

Normal saline DRUG

2ml normal saline

Control Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: parturient
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years or older
• full-term single pregnancy
• had regular prenatal examination
• scheduled for elective cesarean delivery with epidural anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Xu LL, Wang C, Deng CM, Dai SB, Zhou Q, Peng YB, Shou HY, Han YQ, Yu J, Liu CH, Xia F, Zhang SQ, Wang DX, Chen XZ. Efficacy and Safety of Esketamine for Supplemental Analgesia During Elective Cesarean Delivery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e239321. doi: 10.1001/jamanetworkopen.2023.9321.

  PMID: 37083664 DERIVED

MeSH Terms

Interventions

Esketamine; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 16, 2020
• Study Start: September 18, 2021
• Primary Completion: September 20, 2022
• Study Completion: September 30, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)