Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study

Summary

The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section. The target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. This study will be carried out at a single site, the CHU Sainte-Justine as part of a research internship as part of the anesthesiology residency program at the University of Montreal.

Timeline

Start

2022-03-15

Primary completion

2023-01-20

Completion

2023-05-05

Publications

• Background Gu J, Karmakar-Hore S, Hogan ME, Azzam HM, Barrett JFR, Brown A, Cook JL, Jain V, Melamed N, Smith GN, Zaltz A, Gurevich Y. Examining Cesarean Section Rates in Canada Using the Modified Robson Classification. J Obstet Gynaecol Can. 2020 Jun;42(6):757-765. doi: 10.1016/j.jogc.2019.09.009. Epub 2019 Dec 26.
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• Background American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Practice guidelines for obstetric anesthesia: an updated report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia. Anesthesiology. 2007 Apr;106(4):843-63. doi: 10.1097/01.anes.0000264744.63275.10. No abstract available.
• Background Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018.
• Background Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.
• Background Chaney MA. Side effects of intrathecal and epidural opioids. Can J Anaesth. 1995 Oct;42(10):891-903. doi: 10.1007/BF03011037.
• Background Goldberg RF. The Opioid Crisis: The Surgeon's Role. Adv Surg. 2019 Sep;53:305-325. doi: 10.1016/j.yasu.2019.04.015. Epub 2019 May 17. No abstract available.
• Background Volkow ND, Blanco C. The changing opioid crisis: development, challenges and opportunities. Mol Psychiatry. 2021 Jan;26(1):218-233. doi: 10.1038/s41380-020-0661-4. Epub 2020 Feb 4.
• Background Coussens NP, Sittampalam GS, Jonson SG, Hall MD, Gorby HE, Tamiz AP, McManus OB, Felder CC, Rasmussen K. The Opioid Crisis and the Future of Addiction and Pain Therapeutics. J Pharmacol Exp Ther. 2019 Nov;371(2):396-408. doi: 10.1124/jpet.119.259408. Epub 2019 Sep 3.
• Background Pan PH. Post cesarean delivery pain management: multimodal approach. Int J Obstet Anesth. 2006 Jul;15(3):185-8. doi: 10.1016/j.ijoa.2006.04.004. No abstract available.
• Background Li R, Qi F, Zhang J, Ji Y, Zhang D, Shen Z, Lei W. Antinociceptive effects of dexmedetomidine via spinal substance P and CGRP. Transl Neurosci. 2015 Dec 16;6(1):259-264. doi: 10.1515/tnsci-2015-0028. eCollection 2015.
• Background Kerai S, Saxena KN, Taneja B. Post-caesarean analgesia: What is new? Indian J Anaesth. 2017 Mar;61(3):200-214. doi: 10.4103/ija.IJA_313_16.
• Background Sultan P, Halpern SH, Pushpanathan E, Patel S, Carvalho B. The Effect of Intrathecal Morphine Dose on Outcomes After Elective Cesarean Delivery: A Meta-Analysis. Anesth Analg. 2016 Jul;123(1):154-64. doi: 10.1213/ANE.0000000000001255.
• Background Al-Mustafa MM, Abu-Halaweh SA, Aloweidi AS, Murshidi MM, Ammari BA, Awwad ZM, Al-Edwan GM, Ramsay MA. Effect of dexmedetomidine added to spinal bupivacaine for urological procedures. Saudi Med J. 2009 Mar;30(3):365-70.
• Background Qi X, Chen D, Li G, Huang X, Li Y, Wang X, Li Y. Comparison of Intrathecal Dexmedetomidine with Morphine as Adjuvants in Cesarean Sections. Biol Pharm Bull. 2016 Sep 1;39(9):1455-60. doi: 10.1248/bpb.b16-00145. Epub 2016 Jun 28.
• Background Li XX, Li YM, Lv XL, Wang XH, Liu S. The efficacy and safety of intrathecal dexmedetomidine for parturients undergoing cesarean section: a double-blind randomized controlled trial. BMC Anesthesiol. 2020 Aug 3;20(1):190. doi: 10.1186/s12871-020-01109-4.
• Background Bi YH, Wu JM, Zhang YZ, Zhang RQ. Effect of Different Doses of Intrathecal Dexmedetomidine as an Adjuvant Combined With Hyperbaric Ropivacaine in Patients Undergoing Cesarean Section. Front Pharmacol. 2020 Mar 20;11:342. doi: 10.3389/fphar.2020.00342. eCollection 2020.
• Background Kim DJ, Ki YJ, Jang BH, Kim S, Kim SH, Jung KT. Clinically relevant concentrations of dexmedetomidine may reduce oxytocin-induced myometrium contractions in pregnant rats. Anesth Pain Med (Seoul). 2020 Oct 30;15(4):451-458. doi: 10.17085/apm.20036.
• Background Cheng Q, Bi X, Zhang W, Lu Y, Tian H. Dexmedetomidine versus sufentanil with high- or low-concentration ropivacaine for labor epidural analgesia: A randomized trial. J Obstet Gynaecol Res. 2019 Nov;45(11):2193-2201. doi: 10.1111/jog.14104. Epub 2019 Sep 9.
• Background Su F, Gastonguay MR, Nicolson SC, DiLiberto M, Ocampo-Pelland A, Zuppa AF. Dexmedetomidine Pharmacology in Neonates and Infants After Open Heart Surgery. Anesth Analg. 2016 May;122(5):1556-66. doi: 10.1213/ANE.0000000000000869.
• Background Konakci S, Adanir T, Yilmaz G, Rezanko T. The efficacy and neurotoxicity of dexmedetomidine administered via the epidural route. Eur J Anaesthesiol. 2008 May;25(5):403-9. doi: 10.1017/S0265021507003079. Epub 2007 Dec 19.
• Background Solanki SL, Goyal VK. Neuraxial dexmedetomidine: wonder drug or simply harmful. Anesth Pain Med. 2015 Mar 30;5(2):e22651. doi: 10.5812/aapm.22651. eCollection 2015 Apr. No abstract available.
• Background Sanders RD, Sun P, Patel S, Li M, Maze M, Ma D. Dexmedetomidine provides cortical neuroprotection: impact on anaesthetic-induced neuroapoptosis in the rat developing brain. Acta Anaesthesiol Scand. 2010 Jul;54(6):710-6. doi: 10.1111/j.1399-6576.2009.02177.x. Epub 2009 Dec 9.
• Background Celik F, Gocmez C, Kamasak K, Tufek A, Guzel A, Tokgoz O, Firat U, Evliyaoglu O. The comparison of neuroprotective effects of intrathecal dexmedetomidine and metilprednisolone in spinal cord injury. Int J Surg. 2013;11(5):414-8. doi: 10.1016/j.ijsu.2013.03.008. Epub 2013 Mar 28.
• Background Crespo S, Dangelser G, Haller G. Intrathecal clonidine as an adjuvant for neuraxial anaesthesia during caesarean delivery: a systematic review and meta-analysis of randomised trials. Int J Obstet Anesth. 2017 Nov;32:64-76. doi: 10.1016/j.ijoa.2017.06.009. Epub 2017 Jun 27.
• Background Engelman E, Marsala C. Efficacy of adding clonidine to intrathecal morphine in acute postoperative pain: meta-analysis. Br J Anaesth. 2013 Jan;110(1):21-7. doi: 10.1093/bja/aes344. Epub 2012 Sep 21.
• Background Hassenbusch SJ, Gunes S, Wachsman S, Willis KD. Intrathecal clonidine in the treatment of intractable pain: a phase I/II study. Pain Med. 2002 Jun;3(2):85-91. doi: 10.1046/j.1526-4637.2002.02014.x.
• Background Deer TR, Pope JE, Hayek SM, Lamer TJ, Veizi IE, Erdek M, Wallace MS, Grider JS, Levy RM, Prager J, Rosen SM, Saulino M, Yaksh TL, De Andres JA, Abejon Gonzalez D, Vesper J, Schu S, Simpson B, Mekhail N. The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks. Neuromodulation. 2017 Feb;20(2):155-176. doi: 10.1111/ner.12579. Epub 2017 Jan 2.
• Background Schechtmann G, Lind G, Winter J, Meyerson BA, Linderoth B. Intrathecal clonidine and baclofen enhance the pain-relieving effect of spinal cord stimulation: a comparative placebo-controlled, randomized trial. Neurosurgery. 2010 Jul;67(1):173-81. doi: 10.1227/01.NEU.0000370249.41634.4F.
• Background Remy-Neris O, Denys P, Bussel B. Intrathecal clonidine for controlling spastic hypertonia. Phys Med Rehabil Clin N Am. 2001 Nov;12(4):939-51, ix.
• Background Teasell RW, Mehta S, Aubut JA, Foulon B, Wolfe DL, Hsieh JT, Townson AF, Short C; Spinal Cord Injury Rehabilitation Evidence Research Team. A systematic review of pharmacologic treatments of pain after spinal cord injury. Arch Phys Med Rehabil. 2010 May;91(5):816-31. doi: 10.1016/j.apmr.2010.01.022.
• Background Chang E, Ghosh N, Yanni D, Lee S, Alexandru D, Mozaffar T. A Review of Spasticity Treatments: Pharmacological and Interventional Approaches. Crit Rev Phys Rehabil Med. 2013;25(1-2):11-22. doi: 10.1615/CritRevPhysRehabilMed.2013007945.
• Background Pichot C, Longrois D, Ghignone M, Quintin L. [Dexmedetomidine and clonidine: a review of their pharmacodynamy to define their role for sedation in intensive care patients]. Ann Fr Anesth Reanim. 2012 Nov;31(11):876-96. doi: 10.1016/j.annfar.2012.07.018. Epub 2012 Oct 22. French.
• Background Nedashkovsky EV, Sedykh SV, Zakurdaev EI. [USING A VISUAL ANALOGUE SCALE FOR ASSESSING THE SEVERITY OF PAIN SYNDROME AFTER CESAREAN SECTION, DEPENDING ON THE METHOD OF ANESTHESIA.]. Anesteziol Reanimatol. 2016 Sep;61(5):372-376. Russian.
• Background Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
• Background Mizuno M, Fukunaga A, Washio K, Imamura S, Oda Y, Nishigori C. A visual analogue scale for itch and pain in 23 cases of cholinergic urticaria. J Eur Acad Dermatol Venereol. 2020 Sep;34(9):e493-e495. doi: 10.1111/jdv.16410. Epub 2020 May 28. No abstract available.
• Background Craig D, Carli F. Bromage motor blockade score - a score that has lasted more than a lifetime. Can J Anaesth. 2018 Jul;65(7):837-838. doi: 10.1007/s12630-018-1101-7. Epub 2018 Mar 5. No abstract available.
• Background Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.
• Background Bornstein E, Husk G, Lenchner E, Grunebaum A, Gadomski T, Zottola C, Werner S, Hirsch JS, Chervenak FA. Implementation of a Standardized Post-Cesarean Delivery Order Set with Multimodal Combination Analgesia Reduces Inpatient Opioid Usage. J Clin Med. 2020 Dec 22;10(1):7. doi: 10.3390/jcm10010007.

Drugs

Indications

No indication recorded.