Pharmacological ActionNCT03622047
Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil
A study testing Dexmedetomidine ropivacaine and No analgesia labor in people with Pharmacological Action, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 42 years, women only
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- Dexmedetomidine ropivacaine and No analgesia labor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2018to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-Ⅱ, aged 22 - 42,
- gestational age ≥ 37, weight 55 - 90 kg,
- labor analgesia is required by full-term primiparas.
Who cannot join
- serious cardiovascular and cerebrovascular system diseases,
- bradycardia, conduction block
- fetal distress
- contraindications of intraspinal anesthesia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
International Peace Maternity and Child Hospital
Shanghai, Shanghai Municipality, 200030
Yongtao Gao, MD, 86-21-64075389, yankylge@aliyun.com
zeyong yang, MD, 86-21-64070434, zeyongy2018@aliyun.com
About this study
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.
Read the 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.
- Conditions
- Pharmacological Action
- Being tested
- Dexmedetomidine ropivacaine, No analgesia labor
- Keywords
- Labor, Analgesia, Dexmedetomidine, Sufentanil
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine ropivacaineDrug
Also called sufentanil 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.
No analgesia laborDrug
Also called No analgesia labor control
No analgesia labor control group
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine ropivacaine | Experimental | 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. Receives: Drug: Dexmedetomidine ropivacaine; Drug: No analgesia labor |
| sufentanil ropivacaine | Experimental | compare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor. Receives: Drug: Dexmedetomidine ropivacaine; Drug: No analgesia labor |
| No analgesia labor | Experimental | Observing with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality. Receives: Drug: Dexmedetomidine ropivacaine; Drug: No analgesia labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The onset time
A drug's effects to come to prominence upon administration.
Measured: 30 minutes
Secondary outcomes (1)
analgesic effect
VAS Score Visual analogue scale (VAS) of pain before and after analgesia
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start15 Aug 2018
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological ActionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiaxing University Affiliated Women and Children Hospital, Shanghai First Maternity and Infant Hospital
- Responsible party
- Principal investigator, Zeyong Yang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Yongtao Gao, MD, Study director, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622047
- Sponsor's protocol ID
- International Peace Xuhui
- Status last verified
- Feb 2020
- First submitted
- 9 Jul 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil
- ClinicalTrials.gov ID
- NCT03622047
- Acronym / sponsor ID
- International Peace Xuhui
- Conditions
- Pharmacological Action
- Keywords
- Labor, Analgesia, Dexmedetomidine, Sufentanil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Jiaxing University Affiliated Women and Children Hospital, Shanghai First Maternity and Infant Hospital
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine ropivacaine | Experimental | Drug: Dexmedetomidine ropivacaine, Drug: No analgesia laborObserving 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 | Experimental | Drug: Dexmedetomidine ropivacaine, Drug: No analgesia laborcompare the analgesic effects of dexmedetomidine or sufentanil combined with ropivacaine in epidural labor. |
| No analgesia labor | Experimental | Drug: Dexmedetomidine ropivacaine, Drug: No analgesia laborObserving with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality. |
Who may qualify
- Ages
- 22 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-Ⅱ, aged 22 - 42,
- gestational age ≥ 37, weight 55 - 90 kg,
- labor analgesia is required by full-term primiparas.
Key exclusion criteria (4 listed)
- serious cardiovascular and cerebrovascular system diseases,
- bradycardia, conduction block
- fetal distress
- contraindications of intraspinal anesthesia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine ropivacaineAlso: sufentanil ropivacaineObserving 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. | Drug | No analgesia labor, dexmedetomidine ropivacaine, sufentanil ropivacaine |
| No analgesia laborAlso: No analgesia labor controlNo analgesia labor control group | Drug | No analgesia labor, dexmedetomidine ropivacaine, sufentanil ropivacaine |
Primary outcome
The onset time
Time frame: 30 minutes
A drug's effects to come to prominence upon administration.
1 secondary outcome
analgesic effect
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongtao Gao, MD study director
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine ropivacaine and No analgesia labor in people with Pharmacological Action, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zeyong yang, MD, PhD (86-21-64070434, zeyongy2018@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The onset time (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.