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Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil

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ClinicalTrials.gov Identifier: NCT03622047
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : April 2, 2019
Sponsor:
Collaborators:
Women and children’s hospital of Jiaxing university
Shanghai First Maternity and Infant Hospital
Information provided by (Responsible Party):
Zeyong Yang, Shanghai Jiao Tong University School of Medicine

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
Pharmacological Action Drug: Dexmedetomidine ropivacaine Drug: No analgesia labor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 15, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


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 Name: sufentanil ropivacaine

Drug: No analgesia labor
No analgesia labor control group
Other Name: 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 Name: sufentanil ropivacaine

Drug: No analgesia labor
No analgesia labor control group
Other Name: 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 Name: sufentanil ropivacaine

Drug: No analgesia labor
No analgesia labor control group
Other Name: No analgesia labor control




Primary Outcome Measures :
  1. The onset time [ Time Frame: 30 minutes ]
    A drug's effects to come to prominence upon administration.


Secondary Outcome Measures :
  1. analgesic effect [ Time Frame: 1 day ]
    VAS Score Visual analogue scale (VAS) of pain before and after analgesia



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Ages Eligible for Study:   22 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622047


Contacts
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Contact: zeyong yang, MD, PhD 86-21-64070434 zeyongy2018@aliyun.com
Contact: Qiong Meng, MD 86-21-64075389 yankylge@aliyun.com

Locations
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China, Shanghai
International Peace Maternity and Child Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Yongtao Gao, MD    86-21-64075389    yankylge@aliyun.com   
Contact: zeyong yang, MD    86-21-64070434    zeyongy2018@aliyun.com   
Sponsors and Collaborators
Fudan University
Women and children’s hospital of Jiaxing university
Shanghai First Maternity and Infant Hospital
Investigators
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Study Director: Yongtao Gao, MD Shanghai Jiao Tong University School of Medicine

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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     History of Changes
Other Study ID Numbers: International Peace Xuhui
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zeyong Yang, Shanghai Jiao Tong University School of Medicine:
Labor, Analgesia, Dexmedetomidine, Sufentanil
Additional relevant MeSH terms:
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Sufentanil
Dexmedetomidine
Ropivacaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General