Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

NCT ID: NCT03622047

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2020-08-01

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.

Conditions

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Pharmacological Action

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Dexmedetomidine ropivacaine

Intervention Type DRUG

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.

No analgesia labor

Intervention Type DRUG

No analgesia labor control group

sufentanil ropivacaine

compare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor.

Group Type EXPERIMENTAL

Dexmedetomidine ropivacaine

Intervention Type DRUG

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.

No analgesia labor

Intervention Type DRUG

No analgesia labor control group

No analgesia labor

Observing with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.

Group Type EXPERIMENTAL

Dexmedetomidine ropivacaine

Intervention Type DRUG

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.

No analgesia labor

Intervention Type DRUG

No analgesia labor control group

Interventions

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Dexmedetomidine ropivacaine

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.

Intervention Type DRUG

No analgesia labor

No analgesia labor control group

Intervention Type DRUG

Other Intervention Names

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sufentanil ropivacaine No analgesia labor control

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.
Minimum Eligible Age

22 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Women and children's hospital of Jiaxing university

UNKNOWN

Sponsor Role collaborator

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zeyong Yang

Department of Anesthesiology, Principal Investigator, Clinical Professor,International Peace Maternity and Child Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongtao Gao, MD

Role: STUDY_DIRECTOR

Shanghai Jiao Tong University School of Medicine

Locations

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International Peace Maternity and Child Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zeyong yang, MD, PhD

Role: CONTACT

86-21-64070434

Qiong Meng, MD

Role: CONTACT

86-21-64075389

Facility Contacts

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Yongtao Gao, MD

Role: primary

86-21-64075389

zeyong yang, MD

Role: backup

86-21-64070434

Other Identifiers

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International Peace Xuhui

Identifier Type: -

Identifier Source: org_study_id

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