Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia
- Registration Number
- NCT05698407
- Lead Sponsor
- Peking University First Hospital
- Brief 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.
- Detailed Description
Sufentanil combined with ropivacaine is commonly used for epidural labor anesthesia. However, this combination is associated with some adverse events including increased risk of neonatal depression. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist and possesses opioid-sparing and analgesic effects when used in combination with local anesthetics. Recently published data suggest that dexmedetomidine-ropivacaine combination can effectively relieve labor pain.
We suppose that, when compared with traditional sufentanil-ropivacaine combination, the dexmedetomidine-ropivacaine combination used for epidural labor analgesia may reduce sufentanil-related adverse neonatal outcomes. The purpose of this pilot trial is to compare the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination used for epidural labor analgesia on neonatal outcomes, and also to test the feasibility of a future large randomized trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
- Aged 18-45 years;
- Single term pregnancy with vertex presentation planning vaginal delivery;
- Planning to receive epidural labor analgesia.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sufentanil Sufentanil loading dose of 0.45 microgram/ml sufentanil plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml sufentanil plus 0.07% ropivacaine Dexmedetomidine Dexmedetomidine loading dose of 0.45 microgram/ml dexmedetomidine plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml dexmedetomidine plus 0.07% ropivacaine
- Primary Outcome Measures
Name Time Method Composite neonatal morbidity Up to 24 hours after birth Included any of the following: 1-min or 5-min Apgar score less than 7, umbilical cord arterial PH less than 7.1, requirement for immediate assisted ventilation, neonatal intensive care unit or neonatal ward admission within 24 hours after birth.
- Secondary Outcome Measures
Name Time Method Delivery mode At the time of delivery The mode of delivery includes spontaneous delivery, instrumental delivery, and Cesarean delivery.
Epidural infusion volume From the begining of epidural analgesia until childbirth, up to 20 hours Total epidural infusion volume and epidural infusion volume per hour
Duration of labor From the begining of the first stage of labor until delivery of the placenta, up to 20 hours Durations of the first, second, and third stages of labor
The depression score assessed by Edinburgh Postnatal Depression Scale (EPDS) At 42 days after childbirth The depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview. A score of EPDS ≥10 was set as the threshold of postpartum depression.
Subjective sleep quality score at the first night after childbirth Up to 24 hours after childbirth Numeric Rating Scale (NRS) score of subjective sleep quality
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijin, Bejing, China