Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

February 3, 2020 updated by: Zeyong Yang, Fudan University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • International Peace Maternity and Child Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • sufentanil ropivacaine
Drug: No analgesia labor
No analgesia labor control group
Other Names:
  • No analgesia labor control
Experimental: sufentanil ropivacaine
compare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor.
Drug: 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.
Other Names:
  • sufentanil ropivacaine
Drug: No analgesia labor
No analgesia labor control group
Other Names:
  • No analgesia labor control
Experimental: No analgesia labor
Observing with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.
Drug: 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.
Other Names:
  • sufentanil ropivacaine
Drug: No analgesia labor
No analgesia labor control group
Other Names:
  • No analgesia labor control

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Collaborators

Shanghai First Maternity and Infant Hospital
Women and children's hospital of Jiaxing university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

August 4, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • International Peace Xuhui

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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