Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

Not Applicable

• Conditions: Pharmacological Action
• Interventions: Drug: Dexmedetomidine ropivacaine; Drug: No analgesia labor

• Registration Number: NCT03622047
• Lead Sponsor: Fudan University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-08-04
• Study First Posted: 2018-08-09
• Study Start: 2018-08-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1800

Inclusion Criteria

• ASA I-Ⅱ, aged 22 - 42,
• gestational age ≥ 37, weight 55 - 90 kg,
• labor analgesia is required by full-term primiparas.

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Exclusion Criteria

• serious cardiovascular and cerebrovascular system diseases,
• bradycardia, conduction block
• fetal distress
• contraindications of intraspinal anesthesia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sufentanil ropivacaine	Dexmedetomidine ropivacaine	compare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor.
No analgesia labor	Dexmedetomidine ropivacaine	Observing with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.
dexmedetomidine ropivacaine	No analgesia labor	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.
sufentanil ropivacaine	No analgesia labor	compare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor.
No analgesia labor	No analgesia labor	Observing with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.
dexmedetomidine ropivacaine	Dexmedetomidine ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
The onset time	30 minutes	A drug's effects to come to prominence upon administration.

Secondary Outcome Measures

Name	Time	Method
analgesic effect	1 day	VAS Score Visual analogue scale (VAS) of pain before and after analgesia

Trial Locations

Locations (1)

International Peace Maternity and Child Hospital; 🇨🇳 Shanghai, Shanghai, China