Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Dexmedetomidine Plus Ropivacaine Versus Sufentanil Plus Ropivacaine for Epidural Labor Analgesia on Neonatal Outcomes: a Pilot Randomized Trial

Conditions
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Pregnancy Related

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a randomized, double-blind, pilot trial with two parallel-arms
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>loading dose of 0.45 microgram/ml dexmedetomidine plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml dexmedetomidine plus 0.07% ropivacaine | Drug: Dexmedetomidine<br>* A mixture of 0.4 microgram/ml dexmedetomidine plus 0.08% ropivacaine is used for epidural labor analgesia.<br>* Other names: Dexmedetomidine-ropivacaine combination;|
| Active Comparator: Sufentanil<br>loading dose of 0.45 microgram/ml sufentanil plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml sufentanil plus 0.07% ropivacaine | Drug: Sufentanil<br>* A mixture of 0.4 microgrm/ml sufentanil plus 0.08% ropivacaine is used for epidural labor analgesia.<br>* Other names: Sufentanil-ropivacaine combination;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite neonatal morbidity | 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. | Up to 24 hours after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of labor | Durations of the first, second, and third stages of labor | From the begining of the first stage of labor until delivery of the placenta, up to 20 hours | 
| Delivery mode | The mode of delivery includes spontaneous delivery, instrumental delivery, and Cesarean delivery. | At the time of delivery | 
| Epidural infusion volume | Total epidural infusion volume and epidural infusion volume per hour | From the begining of epidural analgesia until childbirth, up to 20 hours | 
| Subjective sleep quality score at the first night after childbirth | Numeric Rating Scale (NRS) score of subjective sleep quality | Up to 24 hours after childbirth | 
| The depression score assessed by Edinburgh Postnatal Depression Scale (EPDS) | 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. | At 42 days after childbirth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural labor analgesia, dexmedetomidine, neonatal outcomes