Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia
NCT ID: NCT07145775
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2025-08-31
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia
NCT05698407
Comparison of Epidural Labor Analgesia With Dexmedetomidine or Sufentanil
NCT03622047
Effect of Sufentanil and Ropivacaine
NCT02488291
Effect of Epidural Hydromorphone Combined With Ropivacaine in Labor Analgesia
NCT05901441
Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia
NCT02036242
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators hypothesize that the dexmedetomidine-esketamine-ropivacaine combination, by avoiding sufentanil and decreasing ropivacaine concentration, may provide non-inferior analgesia with less harmful effect on neonatal outcomes when compared with the sufentanil-ropivacaine combination. This pilot trial is designed to evaluate the efficacy and safety of the dexmedetomidine-esketamine-ropivacaine versus sufentanil-ropivacaine combination for epidural labor analgesia, and to test the feasibility of a future large randomized trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
control group
Epidural analgesia will be conducted with the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine; 100 microgram sufentanil + 18 ml 1% ropivacaine, diluted with normal saline to 250 ml).
sufentanil-ropivacaine combination
Epidural labor analgesia will be conducted using the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine).
experimental group 1
Epidural analgesia will be conducted with the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine; 100 microgram dexmedetomidine + 37.5 mg esketamine + 9 ml 1% ropivacaine, diluted with normal saline to 250 ml).
dexmedetomidine-esketamine-ropivacaine combination 1
Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine).
experimental group 2
Epidural analgesia will be conducted with the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine; 100 microgram dexmedetomidine + 50 mg esketamine + 9 ml 1% ropivacaine, diluted with normal saline to 250 ml).
dexmedetomidine-esketamine-ropivacaine combination 2
Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sufentanil-ropivacaine combination
Epidural labor analgesia will be conducted using the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine).
dexmedetomidine-esketamine-ropivacaine combination 1
Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine).
dexmedetomidine-esketamine-ropivacaine combination 2
Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Single term cephalic pregnancy preparing for vaginal delivery;
3. Agreed to receive epidural labor analgesia.
Exclusion Criteria
2. Presence of contraindications for epidural analgesia, including: (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.
3. Relative contraindications for the use of dexmedetomidine, including prenatal bradycardia (HR\<60 beats per minute) and second-degree or higher atrioventricular block;
4. Relative contraindications for the use of esketamine, including uncontrolled hypertension (systolic blood pressure \>180 mmHg) and hyperthyroidism;
5. Not well controlled systemic diseases, including heart disease, liver disease, kidney disease, or an ASA classification \>III;
6. Other conditions that are considered unsuitable for study participation.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University First Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dong-Xin Wang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Lou S, Du Q, Yu L, Wang Q, Yu J, Mei Z. ED90 of epidural esketamine with 0.075% ropivacaine for labor analgesia in nulliparous parturients: a prospective, randomized and dose-finding study. Front Pharmacol. 2023 May 5;14:1169415. doi: 10.3389/fphar.2023.1169415. eCollection 2023.
Zhang Y, Cui F, Ma JH, Wang DX. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial. Br J Anaesth. 2023 Aug;131(2):385-396. doi: 10.1016/j.bja.2023.05.001. Epub 2023 Jun 9.
Li K, Chai Z, Deng C, Niu G, Geng X, Zhang Y, Wang Y, Wang T. Effects of epidural esketamine versus sufentanil on labor analgesia and postpartum depression: a retrospective cohort study. BMC Anesthesiol. 2025 Jan 7;25(1):6. doi: 10.1186/s12871-024-02846-6.
Xu L, Li S, Zhang C, Zhou Y, Chen X. Esketamine administered epidurally as an adjuvant to epidural ropivacaine for labour analgesia: a prospective, double-blind dose-response study. BMJ Open. 2024 Nov 2;14(11):e071818. doi: 10.1136/bmjopen-2023-071818.
Richards ND, Howell SJ, Bellamy MC, Beck J. The diverse effects of ketamine, jack-of-all-trades: a narrative review. Br J Anaesth. 2025 Mar;134(3):649-661. doi: 10.1016/j.bja.2024.11.018. Epub 2025 Jan 2.
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.
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.
Rao S, Rajan N. Dexmedetomidine as an Adjunct for Regional Anesthetic Nerve Blocks. Curr Pain Headache Rep. 2021 Feb 3;25(2):8. doi: 10.1007/s11916-020-00926-z.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025R0269
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.