Pregnancy Related
Conditions
Keywords
epidural labor analgesia, dexmedetomidine, neonatal outcomes
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.
Interventions
DRUGDexmedetomidine
loading dose of 0.45 microgram/ml dexmedetomidine plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml dexmedetomidine plus 0.07% ropivacaine.
DRUGSufentanil
loading dose of 0.45 microgram/ml sufentanil plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml sufentanil plus 0.07% ropivacaine.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
All participants, attending anesthesiologists and other health-care team members, and outcome assessors are blinded to the study group assignment.
Intervention model description
a randomized, double-blind, pilot trial with two parallel-arms
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 18-45 years; 2. Single term pregnancy with vertex presentation planning vaginal delivery; 3. Planning to receive epidural labor analgesia.
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 or hepatic, renal or cardiac disease), American Society of Anesthesiologists (ASA) physical status ≥3. 3. History of psychiatric disease or epilepsia. 4. Allergy to study agents. 5. Other conditions that are considered unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
Countries
China
Outcome results
None listed