drugset / Trial / NCT06060015
Effect of Subarachnoid Hyperbaric Bupivacaine in Obese Pregnant Patients Undergoing Cesarean Section
RandomizedParallel-groupDouble-blindSupportive care
Summary
Evaluates the effect of hyperbaric subarachnoid bupivacaine at doses of 5 mg vs 10 mg on mean arterial pressure in obese pregnant patients undergoing cesarean section
Timeline
- Start
- 2023-08-01
- Primary completion
- 2024-10-31
- Completion
- 2024-12-31
Publications
- Background Eltzschig HK, Lieberman ES, Camann WR. Regional anesthesia and analgesia for labor and delivery. N Engl J Med. 2003 Jan 23;348(4):319-32. doi: 10.1056/NEJMra021276. No abstract available.
- Results Badve MH, Golfeiz C, Vallejo MC. Anesthetic considerations for the morbid obese parturient. Int Anesthesiol Clin. 2014 Summer;52(3):132-47. doi: 10.1097/AIA.0000000000000024. No abstract available.
- Results Tonidandel A, Booth J, D'Angelo R, Harris L, Tonidandel S. Anesthetic and obstetric outcomes in morbidly obese parturients: a 20-year follow-up retrospective cohort study. Int J Obstet Anesth. 2014 Nov;23(4):357-64. doi: 10.1016/j.ijoa.2014.05.004. Epub 2014 Jun 4.
- Results Ouzounian JG, Elkayam U. Physiologic changes during normal pregnancy and delivery. Cardiol Clin. 2012 Aug;30(3):317-29. doi: 10.1016/j.ccl.2012.05.004. Epub 2012 Jun 20.
- Results Hood DD, Dewan DM. Anesthetic and obstetric outcome in morbidly obese parturients. Anesthesiology. 1993 Dec;79(6):1210-8. doi: 10.1097/00000542-199312000-00011.
- Results Tan T, Sia AT. Anesthesia considerations in the obese gravida. Semin Perinatol. 2011 Dec;35(6):350-5. doi: 10.1053/j.semperi.2011.05.021.
- Results Ngan Kee WD, Khaw KS, Tan PE, Ng FF, Karmakar MK. Placental transfer and fetal metabolic effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery. Anesthesiology. 2009 Sep;111(3):506-12. doi: 10.1097/ALN.0b013e3181b160a3.
- Results Lee Y, Balki M, Parkes R, Carvalho JC. Dose requirement of intrathecal bupivacaine for cesarean delivery is similar in obese and normal weight women. Rev Bras Anestesiol. 2009 Nov-Dec;59(6):674-83. doi: 10.1016/s0034-7094(09)70092-3. English, Portuguese.
- Results Carvalho B, Collins J, Drover DR, Atkinson Ralls L, Riley ET. ED(50) and ED(95) of intrathecal bupivacaine in morbidly obese patients undergoing cesarean delivery. Anesthesiology. 2011 Mar;114(3):529-35. doi: 10.1097/ALN.0b013e318209a92d.
- Results Reyes M, Pan PH. Very low-dose spinal anesthesia for cesarean section in a morbidly obese preeclamptic patient and its potential implications. Int J Obstet Anesth. 2004 Apr;13(2):99-102. doi: 10.1016/j.ijoa.2003.09.004.
- Results Teoh WH, Thomas E, Tan HM. Ultra-low dose combined spinal-epidural anesthesia with intrathecal bupivacaine 3.75 mg for cesarean delivery: a randomized controlled trial. Int J Obstet Anesth. 2006 Oct;15(4):273-8. doi: 10.1016/j.ijoa.2006.03.004. Epub 2006 Jun 13.
- Results Bamgbade OA, Khalaf WM, Ajai O, Sharma R, Chidambaram V, Madhavan G. Obstetric anaesthesia outcome in obese and non-obese parturients undergoing caesarean delivery: an observational study. Int J Obstet Anesth. 2009 Jul;18(3):221-5. doi: 10.1016/j.ijoa.2008.07.013. Epub 2009 May 17.
- Results Nani FS, Torres ML. Correlation between the body mass index (BMI) of pregnant women and the development of hypotension after spinal anesthesia for cesarean section. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):21-30. doi: 10.1016/S0034-7094(11)70003-4.
- Results Ngaka TC, Coetzee JF, Dyer RA. The Influence of Body Mass Index on Sensorimotor Block and Vasopressor Requirement During Spinal Anesthesia for Elective Cesarean Delivery. Anesth Analg. 2016 Dec;123(6):1527-1534. doi: 10.1213/ANE.0000000000001568.
- Results Hassanin AS, El-Shahawy HF, Hussain SH, Bahaa Eldin AM, Elhawary MM, Elbakery M, Elsafty MSE. Impact of interval between induction of spinal anesthesia to delivery on umbilical arterial cord ph of neonates delivered by elective cesarean section. BMC Pregnancy Childbirth. 2022 Mar 17;22(1):216. doi: 10.1186/s12884-022-04536-y.
- Results Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
- Results Zhu T, Tang J, Zhao F, Qu Y, Mu D. Association between maternal obesity and offspring Apgar score or cord pH: a systematic review and meta-analysis. Sci Rep. 2015 Dec 22;5:18386. doi: 10.1038/srep18386.
- Results Soens MA, Birnbach DJ, Ranasinghe JS, van Zundert A. Obstetric anesthesia for the obese and morbidly obese patient: an ounce of prevention is worth more than a pound of treatment. Acta Anaesthesiol Scand. 2008 Jan;52(1):6-19. doi: 10.1111/j.1399-6576.2007.01483.x.
- Results Ring LE. The anesthetic approach to operative delivery of the extremely obese parturient. Semin Perinatol. 2014 Oct;38(6):341-8. doi: 10.1053/j.semperi.2014.07.008. Epub 2014 Aug 19.
- Results Kominiarek MA, Chauhan SP. Obesity Before, During, and After Pregnancy: A Review and Comparison of Five National Guidelines. Am J Perinatol. 2016 Apr;33(5):433-41. doi: 10.1055/s-0035-1567856. Epub 2015 Nov 20.
- Results Silva JC, Amaral AR, Ferreira BD, Petry JF, Silva MR, Krelling PC. [Obesity during pregnancy: gestational complications and birth outcomes.]. Rev Bras Ginecol Obstet. 2014 Nov;36(11):509-513. doi: 10.1590/s0100-720320140005024. Epub 2014 Nov 1. Portuguese.
- Results Lamon AM, Habib AS. Managing anesthesia for cesarean section in obese patients: current perspectives. Local Reg Anesth. 2016 Aug 16;9:45-57. doi: 10.2147/LRA.S64279. eCollection 2016.
- Results Dennis AT, Castro JM, Ong M, Carr C. Haemodynamics in obese pregnant women. Int J Obstet Anesth. 2012 Apr;21(2):129-34. doi: 10.1016/j.ijoa.2011.11.007. Epub 2012 Feb 11.
- Results Rodrigues FR, Brandao MJ. Regional anesthesia for cesarean section in obese pregnant women: a retrospective study. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):13-20. doi: 10.1016/S0034-7094(11)70002-2.
- Results Wise RA, Polito AJ, Krishnan V. Respiratory physiologic changes in pregnancy. Immunol Allergy Clin North Am. 2006 Feb;26(1):1-12. doi: 10.1016/j.iac.2005.10.004.
- Results Kim ST. Anesthetic management of obese and morbidly obese parturients. Anesth Pain Med (Seoul). 2021 Oct;16(4):313-321. doi: 10.17085/apm.21090. Epub 2021 Oct 29.
- Results Chandra S, Tripathi AK, Mishra S, Amzarul M, Vaish AK. Physiological changes in hematological parameters during pregnancy. Indian J Hematol Blood Transfus. 2012 Sep;28(3):144-6. doi: 10.1007/s12288-012-0175-6. Epub 2012 Jul 15.
- Results American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 549: obesity in pregnancy. Obstet Gynecol. 2013 Jan;121(1):213-7. doi: 10.1097/01.aog.0000425667.10377.60.
- Results Gaiser R. Anesthetic Considerations in the Obese Parturient. Clin Obstet Gynecol. 2016 Mar;59(1):193-203. doi: 10.1097/GRF.0000000000000180.
- Results Arias J, Lacassie HJ. [Prophylaxis and treatment of arterial hypotension during caesarean with spinal anaesthesia]. Rev Esp Anestesiol Reanim. 2013 Nov;60(9):511-8. doi: 10.1016/j.redar.2012.07.023. Epub 2012 Oct 23. Spanish.
- Results Davies GAL, Maxwell C, McLeod L. No. 239-Obesity in Pregnancy. J Obstet Gynaecol Can. 2018 Aug;40(8):e630-e639. doi: 10.1016/j.jogc.2018.05.018.
- Results Rasolonjatovo TY, Ravololonirina BM, Randriamanantany ZA, Raveloson NE. [Spinal anesthesia for cesarean section: risk factors for emergence of Apgar scores below 7 in Malagasy newborns]. Pan Afr Med J. 2014 Oct 23;19:193. doi: 10.11604/pamj.2014.19.193.3392. eCollection 2014. French.
- Results Mercier FJ, Auge M, Hoffmann C, Fischer C, Le Gouez A. Maternal hypotension during spinal anesthesia for caesarean delivery. Minerva Anestesiol. 2013 Jan;79(1):62-73. Epub 2012 Nov 18.
- Results Polin CM, Hale B, Mauritz AA, Habib AS, Jones CA, Strouch ZY, Dominguez JE. Anesthetic management of super-morbidly obese parturients for cesarean delivery with a double neuraxial catheter technique: a case series. Int J Obstet Anesth. 2015 Aug;24(3):276-80. doi: 10.1016/j.ijoa.2015.04.001. Epub 2015 Apr 8.
- Results Sng BL, Siddiqui FJ, Leong WL, Assam PN, Chan ES, Tan KH, Sia AT. Hyperbaric versus isobaric bupivacaine for spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2016 Sep 15;9(9):CD005143. doi: 10.1002/14651858.CD005143.pub3.
- Results Lamon AM, Einhorn LM, Cooter M, Habib AS. The impact of body mass index on the risk of high spinal block in parturients undergoing cesarean delivery: a retrospective cohort study. J Anesth. 2017 Aug;31(4):552-558. doi: 10.1007/s00540-017-2352-0. Epub 2017 Apr 18.
- Results Edwards RK, Cantu J, Cliver S, Biggio JR Jr, Owen J, Tita ATN. The association of maternal obesity with fetal pH and base deficit at cesarean delivery. Obstet Gynecol. 2013 Aug;122(2 Pt 1):262-267. doi: 10.1097/AOG.0b013e31829b1e62.
- Results Hollowell J, Pillas D, Rowe R, Linsell L, Knight M, Brocklehurst P. The impact of maternal obesity on intrapartum outcomes in otherwise low risk women: secondary analysis of the Birthplace national prospective cohort study. BJOG. 2014 Feb;121(3):343-55. doi: 10.1111/1471-0528.12437. Epub 2013 Sep 11.
- Results Committee Membership:; Burns S, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Kirshblum S, Mulcahey MJ, Read MS, Waring W. International standards for neurological classification of spinal cord injury, revised 2011. Top Spinal Cord Inj Rehabil. 2012 Winter;18(1):85-99. doi: 10.1310/sci1801-85. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | 5 mg | Other |
| Subject | Bupivacaine | Other / unclassified | 10 mg | Other |
Indications
No indication recorded.