Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

Study Overview
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Brief Summary
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The participants: 1800 full-term primiparas will be selected with ASA I-Ⅱgrade, 20 to 35 years old and weighing 55 to 90 kg in the investigator's hospital from may 2018 to December 2018. 1200 primiparas were divided into A and B according to the computer randomized numbers, and 600 parturients without labor analgesia in the same period were selected as group C, with 600 patients in each group. All parturients signed the informed consent form and were approved by the hospital ethics Committee.

Detailed Description
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1200 primiparas were divided into A and B according to the computer randomized numbers, and 600 parturients without labor analgesia in the same period were selected as group C, with 600 patients in each group. All parturients signed the informed consent form and were approved by the hospital ethics Committee.

Official Title
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Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

Conditions
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Pharmacological Action

Intervention / Treatment
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* Drug: Dexmedetomidine ropivacaine
* Drug: No analgesia labor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-Ⅱ, aged 22 - 42, gestational age ≥ 37, weight 55 - 90 kg, labor analgesia is required by full-term primiparas. Exclusion Criteria: serious cardiovascular and cerebrovascular system diseases, bradycardia, conduction block fetal distress contraindications of intraspinal anesthesia.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine ropivacaine<br>Observing 0.5 μ g / ml dexmedetomidine + 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality. | Drug: Dexmedetomidine ropivacaine<br>* Observing the effect of 0.5 μ g / ml sufentanil+ 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.<br>* Other names: sufentanil ropivacaine;Drug: No analgesia labor<br>* No analgesia labor control group<br>* Other names: No analgesia labor control;|
| Experimental: sufentanil ropivacaine<br>compare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor. | Drug: Dexmedetomidine ropivacaine<br>* Observing the effect of 0.5 μ g / ml sufentanil+ 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.<br>* Other names: sufentanil ropivacaine;Drug: No analgesia labor<br>* No analgesia labor control group<br>* Other names: No analgesia labor control;|
| Experimental: No analgesia labor<br>Observing with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality. | Drug: Dexmedetomidine ropivacaine<br>* Observing the effect of 0.5 μ g / ml sufentanil+ 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.<br>* Other names: sufentanil ropivacaine;Drug: No analgesia labor<br>* No analgesia labor control group<br>* Other names: No analgesia labor control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The onset time | A drug's effects to come to prominence upon administration. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic effect | VAS Score Visual analogue scale (VAS) of pain before and after analgesia | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor, Analgesia, Dexmedetomidine, Sufentanil