Dexmedetomidine Versus Sufentanil Plus Ropivacaine for Epidural Labor Analgesia on Neonatal Outcomes

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: Female

Summary

Sufentanil is commonly used with ropivacaine in epidural labor anesthesia. However, it can cause some adverse reaction. Dexmedetomidine is an a2-adrenoceptor agonist with high selectivity, which possesses opioid-sparing and analgesic effects. Published researches have shown that the ropivacaine combined with dexmedetomidine can effectively relieve postoperative pain. The purpose of this present study is to compare the effect of ropivacaine with dexmedetomidine against ropivacaine with sufentanil in epidural labor analgesia on neonatal outcomes, and also tested the feasibility of a future large randomized trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Peking University First Hospital
• Treatments: Dexmedetomidine; Ropivacaine; Sufentanil

Criteria

Inclusion Criteria:

greater than 18 years of age; term pregnancy (greater than 37 gestational weeks); planning epidural labor analgesia; singleton pregnancy; vertex presentation; planned vaginal delivery.

Exclusion Criteria:

1. 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.

2. Existence of bradycardia (heart rate < 60 bpm), hypotension (SBP < 90 mmHg) or severe hypertension (SBP ≥ 180mmHg), Uncontrolled systemic comorbidities [i.e., diabetes, hepatic, renal or cardiac], American Society of Anesthesiologists (ASA) Physical Status ≥ 3.

3. History of psychiatric disease.

4. Allergy to study agents.

5. Inability to communicate or participate in study procedures.