drugset / Trial / NCT05698407
Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia
RandomizedParallel-groupTriple-blindPrevention
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. 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.
Timeline
- Start
- 2023-03-16
- Primary completion
- 2023-06-15
- Completion
- 2023-08-28
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexmedetomidine | Other / unclassified | 0.36 ug/ml | Other |
| Comparator | Sufentanil | Other / unclassified | 0.36 ug/ml | Other |
| Background | Ropivacaine | Other / unclassified | 0.07 % | Other |