drugset / Trial / NCT07145775
Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Plenty of evidences show that both dexmedetomidine and esketamine, combined with ropivacaine, are also effective as the sufentanil-ropivacaine combination when used for epidural labor analgesia. 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.
Timeline
- Start
- 2025-09-05
- Primary completion
- 2026-01-29
- Completion
- 2026-03-13
Publications
- Background 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.4 ug/ml | Other |
| Subject | Esketamine | Other / unclassified | 0.15 mg/ml | Other |
| Subject | Esketamine | Other / unclassified | 0.2 mg/ml | Other |
| Subject | Ropivacaine | Other / unclassified | 0.036 % | Other |
| Subject | Ropivacaine | Other / unclassified | 0.072 % | Other |
| Comparator | Sufentanil | Other / unclassified | 0.4 ug/ml | Other |
Indications
No indication recorded.