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A comparative study of the effects of esketamine and sufentanil for epidural labor analgesia on EC50 and EC95 of ropivacaine

A comparative study of the effects of esketamine and sufentanil for epidural labor analgesia on EC50 and EC95 of ropivacaine

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081373
Enrollment
Unknown
Registered
2024-02-29
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Interventions

Sufentanil group:Sufentanil 0.3ug/ml
Esketamine group:Esketamine 0.5mg/ml

Sponsors

Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Parturients aged 20-50 years with ASA II, BMI 18.5-30,healthy singleton pregnancies at term (=37 weeks gestational age), spontaneous onset of labor, latent phase of labor with cervical dilation of 2–5 cm, and painful contractions requiring labor epidural analgesia, without electrolyte disorders as well as infectious, immunologic, Endocrine system diseases.

Exclusion criteria

Exclusion criteria: parturients suffering from psychiatric and central nervous system disorders, liver disease, renal function abnormalities, cardiopulmonary function abnormalities, diabetes mellitus;severe obstetric comorbidities and complications such as pre-eclampsia and eclampsia, hyperemesis gravidarum, placenta previa, placenta previa; stillbirth; neonatal malformation; Contraindications to the use of esketamine exist (e.g., hypertension, tachycardia, hypersensitivity to esketamine and its components, etc.);Parturients with contraindications to neuraxial anesthesia; abnormal coagulation function; recent use of cardiovascular drugs, sedative and analgesic drugs, hormonal drugs, anti-psychotic drugs and anticoagulant drugs; severe hypovolemia and hemodynamic instability, as well as refusing to participate.

Design outcomes

Primary

MeasureTime frame
EC50 of ropivacaine in each group;

Secondary

MeasureTime frame
EC95 of ropivacaine in each group;Total ropivacaine consumption in each group;The total number of PCEA boluses;Durations of labour;Mode of delivery;Bromage score;The NRS score of maternal pain;The Ramsay sedation scale score;Mean arterial pressure, heart rate and SpO2 of each parturient;Neonatal Apgar score assessed at 1 and 5 minutes after birth;The incidence of adverse events;

Countries

China

Contacts

Public ContactLili Xu

Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

xulili@zju.edu.cn+86 138 5811 5478

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026