Status:
NOT_YET_RECRUITING
Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia
Lead Sponsor:
Peking University First Hospital
Conditions:
Epidural Analgesia
Labor Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neurax...
Detailed Description
Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neurax...
Eligibility Criteria
Inclusion
- Aged 18 years or above;
- Single term cephalic pregnancy preparing for vaginal delivery;
- Agreed to receive epidural labor analgesia.
Exclusion
- History of schizophrenia or epilepsy;
- Presence of contraindications for epidural analgesia, including: (1) history of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) history of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) systemic infection (sepsis); (4) skin or soft tissue infection at the site of epidural puncture; (5) coagulopathy.
- Relative contraindications for the use of dexmedetomidine, including prenatal bradycardia (HR\<60 beats per minute) and second-degree or higher atrioventricular block;
- Relative contraindications for the use of esketamine, including uncontrolled hypertension (systolic blood pressure \>180 mmHg) and hyperthyroidism;
- Not well controlled systemic diseases, including heart disease, liver disease, kidney disease, or an ASA classification \>III;
- Other conditions that are considered unsuitable for study participation.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07145775
Start Date
August 1 2025
End Date
October 1 2026
Last Update
August 28 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034