Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil
1 other identifier
interventional
1,800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedStudy Start
First participant enrolled
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedFebruary 5, 2020
February 1, 2020
2 years
July 9, 2018
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The onset time
A drug's effects to come to prominence upon administration.
30 minutes
Secondary Outcomes (1)
analgesic effect
1 day
Study Arms (3)
dexmedetomidine ropivacaine
EXPERIMENTALObserving 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
EXPERIMENTALcompare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor.
No analgesia labor
EXPERIMENTALObserving with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.
Interventions
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 control group
Eligibility Criteria
You may qualify if:
- ASA I-Ⅱ, aged 22 - 42,
- gestational age ≥ 37, weight 55 - 90 kg,
- labor analgesia is required by full-term primiparas.
You may not qualify if:
- serious cardiovascular and cerebrovascular system diseases,
- bradycardia, conduction block
- fetal distress
- contraindications of intraspinal anesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
- Women and children's hospital of Jiaxing universitycollaborator
- Shanghai First Maternity and Infant Hospitalcollaborator
Study Sites (1)
International Peace Maternity and Child Hospital
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yongtao Gao, MD
Shanghai Jiao Tong University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Anesthesiology, Principal Investigator, Clinical Professor,International Peace Maternity and Child Hospital
Study Record Dates
First Submitted
July 9, 2018
First Posted
August 9, 2018
Study Start
August 15, 2018
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share