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Pregnancy RelatedPhase 4NCT05698407

Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia

A Phase 4 study testing Dexmedetomidine and Sufentanil in people with Pregnancy Related, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist. Mounting evidences show that dexmedetomidine-ropivacaine combination can also be used effectively for epidural labor analgesia. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related
What is being tested?
Dexmedetomidine and Sufentanil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
16 Mar 2023to 28 Aug 2023
Phase
Phase 4
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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged 18-45 years;
  • Single term pregnancy with vertex presentation planning vaginal delivery;
  • Planning to receive epidural labor analgesia.

Who cannot join

  • Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy.
  • Existence of bradycardia (heart rate <60 bpm), hypotension (SBP <90 mmHg) or severe hypertension (SBP ≥180mmHg), uncontrolled systemic comorbidities (i.e., diabetes or hepatic, renal or cardiac disease), American Society of Anesthesiologists (ASA) physical status ≥3.
  • History of psychiatric disease or epilepsia.
  • Allergy to study agents.
  • Other conditions that are considered unsuitable for study participation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijin, Bejing, 100034

Other trials in China

About this study

Official title: Effect of Dexmedetomidine Plus Ropivacaine Versus Sufentanil Plus Ropivacaine for Epidural Labor Analgesia on Neonatal Outcomes: a Pilot Randomized Trial

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist. Mounting evidences show that dexmedetomidine-ropivacaine combination can also be used effectively for epidural labor analgesia. This pilot trial is designed to compare the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination on neonatal outcomes when used for epidural labor analgesia, and to test the feasibility of a future large randomized trial.

Read the detailed description

Sufentanil combined with ropivacaine is commonly used for epidural labor anesthesia. However, this combination is associated with some adverse events including increased risk of neonatal depression. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist and possesses opioid-sparing and analgesic effects when used in combination with local anesthetics. Recently published data suggest that dexmedetomidine-ropivacaine combination can effectively relieve labor pain.

We suppose that, when compared with traditional sufentanil-ropivacaine combination, the dexmedetomidine-ropivacaine combination used for epidural labor analgesia may reduce sufentanil-related adverse neonatal outcomes. The purpose of this pilot trial is to compare the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination used for epidural labor analgesia on neonatal outcomes, and also to test the feasibility of a future large randomized trial.

Being tested
Dexmedetomidine, Sufentanil
Keywords
epidural labor analgesia, dexmedetomidine, neonatal outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Dexmedetomidine-ropivacaine combination

    loading dose of 0.45 microgram/ml dexmedetomidine plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml dexmedetomidine plus 0.07% ropivacaine.

  • SufentanilDrug

    Also called Sufentanil-ropivacaine combination

    loading dose of 0.45 microgram/ml sufentanil plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml sufentanil plus 0.07% ropivacaine.

Study groups in NCT05698407
Study groupRoleWhat they receive
DexmedetomidineExperimentalloading dose of 0.45 microgram/ml dexmedetomidine plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml dexmedetomidine plus 0.07% ropivacaine
Receives: Drug: Dexmedetomidine
SufentanilActive comparatorloading dose of 0.45 microgram/ml sufentanil plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml sufentanil plus 0.07% ropivacaine
Receives: Drug: Sufentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite neonatal morbidity

    Included any of the following: 1-min or 5-min Apgar score less than 7, umbilical cord arterial PH less than 7.1, requirement for immediate assisted ventilation, neonatal intensive care unit or neonatal ward admission within 24 hours after birth.

    Measured: Up to 24 hours after birth

Secondary outcomes (5)

  1. Duration of labor

    Durations of the first, second, and third stages of labor

    Measured: From the begining of the first stage of labor until delivery of the placenta, up to 20 hours

  2. Delivery mode

    The mode of delivery includes spontaneous delivery, instrumental delivery, and Cesarean delivery.

    Measured: At the time of delivery

  3. Epidural infusion volume

    Total epidural infusion volume and epidural infusion volume per hour

    Measured: From the begining of epidural analgesia until childbirth, up to 20 hours

  4. Subjective sleep quality score at the first night after childbirth

    Numeric Rating Scale (NRS) score of subjective sleep quality

    Measured: Up to 24 hours after childbirth

  5. The depression score assessed by Edinburgh Postnatal Depression Scale (EPDS)

    The depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview. A score of EPDS ≥10 was set as the threshold of postpartum depression.

    Measured: At 42 days after childbirth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start16 Mar 2023
  3. Primary completion15 Jun 2023
  4. Study completion28 Aug 2023

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
a randomized, double-blind, pilot trial with two parallel-arms
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05698407
Sponsor's protocol ID
2022-368
Status last verified
Dec 2023
First submitted
16 Jan 2023
Last updated
3 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee AI, McCarthy RJ, Toledo P, Jones MJ, White N, Wong CA. Epidural Labor Analgesia-Fentanyl Dose and Breastfeeding Success: A Randomized Clinical Trial. Anesthesiology. 2017 Oct;127(4):614-624. doi: 10.1097/ALN.0000000000001793.

    PubMed 28926440

  • Armstrong S, Fernando R. Side Effects and Efficacy of Neuraxial Opioids in Pregnant Patients at Delivery: A Comprehensive Review. Drug Saf. 2016 May;39(5):381-99. doi: 10.1007/s40264-015-0386-5.

    PubMed 26832926

  • Hussain N, Grzywacz VP, Ferreri CA, Atrey A, Banfield L, Shaparin N, Vydyanathan A. Investigating the Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthesia in Brachial Plexus Block: A Systematic Review and Meta-Analysis of 18 Randomized Controlled Trials. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):184-196. doi: 10.1097/AAP.0000000000000564.

    PubMed 28178091

  • Hetta DF, Fares KM, Abedalmohsen AM, Abdel-Wahab AH, Elfadl GMA, Ali WN. Epidural dexmedetomidine infusion for perioperative analgesia in patients undergoing abdominal cancer surgery: randomized trial. J Pain Res. 2018 Oct 30;11:2675-2685. doi: 10.2147/JPR.S163975. eCollection 2018.

    PubMed 30464585

  • Qian M, Gao F, Liu J, Xu P. Dexmedetomidine versus fentanyl as adjuvants to ropivacaine for epidural anaesthesia: A systematic review and meta-analysis. Int J Clin Pract. 2021 May;75(5):e13772. doi: 10.1111/ijcp.13772. Epub 2020 Dec 20.

    PubMed 33078536

  • Zhang X, Wang D, Shi M, Luo Y. Efficacy and Safety of Dexmedetomidine as an Adjuvant in Epidural Analgesia and Anesthesia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):343-354. doi: 10.1007/s40261-016-0477-9.

    PubMed 27812971

  • Liu L, Drzymalski D, Xu W, Zhang W, Wang L, Xiao F. Dose dependent reduction in median effective concentration (EC50) of ropivacaine with adjuvant dexmedetomidine in labor epidural analgesia: An up-down sequential allocation study. J Clin Anesth. 2021 Feb;68:110115. doi: 10.1016/j.jclinane.2020.110115. Epub 2020 Nov 1.

    PubMed 33142249

  • Jin KX, Deng CM, Ding T, Qu Y, Wang DX. Impact of dexmedetomidine-ropivacaine versus sufentanil-ropivacaine combination for epidural labour analgesia on neonatal outcomes: a pilot randomised clinical trial. BMJ Open. 2024 Dec 22;14(12):e090208. doi: 10.1136/bmjopen-2024-090208.

    PubMed 39806707

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and Sufentanil in people with Pregnancy Related, run by Peking University First Hospital 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 5 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: finished, as of the sponsor's last update on 3 Jan 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite neonatal morbidity (time frame: Up to 24 hours after birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05698407, which also lists 8 linked publications.

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 3 Jan 2024.

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