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Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

Sponsor
Fudan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03622047
Collaborator
Women and children's hospital of Jiaxing university (Other), Shanghai First Maternity and Infant Hospital (Other)
1,800
Enrollment
1
Location
3
Arms
23.6
Anticipated Duration (Months)
76.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexmedetomidine ropivacaine
  • Drug: No analgesia labor
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil
Actual Study Start Date :
Aug 15, 2018
Anticipated Primary Completion Date :
Aug 1, 2020
Anticipated Study Completion Date :
Aug 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The onset time [30 minutes]

      A drug's effects to come to prominence upon administration.

    Secondary Outcome Measures

    1. analgesic effect [1 day]

      VAS Score Visual analogue scale (VAS) of pain before and after analgesia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 International Peace Maternity and Child Hospital Shanghai Shanghai China 200030

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Yongtao Gao, MD, Shanghai Jiao Tong University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zeyong Yang, Department of Anesthesiology, Principal Investigator, Clinical Professor,International Peace Maternity and Child Hospital, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03622047
    Other Study ID Numbers:
    • International Peace Xuhui
    First Posted:
    Aug 9, 2018
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zeyong Yang, Department of Anesthesiology, Principal Investigator, Clinical Professor,International Peace Maternity and Child Hospital, Shanghai Jiao Tong University School of Medicine
    Labor, Analgesia, Dexmedetomidine, Sufentanil
    Additional relevant MeSH terms:
    Sufentanil
    Dexmedetomidine
    Ropivacaine

    Study Results

    No Results Posted as of Feb 5, 2020