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NCT05698407
Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia
Conditions: Pregnancy Related
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 200
Sponsor: Peking University First Hospital
Summary
Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events.
Dexmedetomidine is a high selective alpha2-adrenoceptor agonist.
Mounting evidences show that dexmedetomidine-ropivacaine combination can also be used effectively for epidural labor analgesia.
This pilot trial is designed to compare the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination on neonatal outcomes when used for epidural labor analgesia, and to test the feasibility of a future large randomized trial.
Eligibility Criteria
Inclusion Criteria:Aged 18-45 years;Single term pregnancy with vertex presentation planning vaginal delivery;Planning to receive epidural labor analgesia.Exclusion Criteria:Presence of contraindications to epidural analgesia, which includes: (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.Existence of bradycardia (heart rate <60 bpm), hypotension (SBP <90 mmHg) or severe hypertension (SBP ≥180mmHg), uncontrolled systemic comorbidities (i.e., diabetes or hepatic, renal or cardiac disease), American Society of Anesthesiologists (ASA) physical status ≥3.History of psychiatric disease or epilepsia.Allergy to study agents.Other conditions that are considered unsuitable for study participation.
Source: ClinicalTrials.gov (NCT05698407). StuddyBuddy aggregates publicly available trial information.