drugset / Trial / NCT03834454
Bupivacaine 5 mg vs 7.5 mg for Spinal Anesthesia in Cesarean Delivery in Indonesian Population
RandomizedParallel-groupDouble-blindSupportive care
Summary
This study aims to evaluate the efficacy of hyperbaric 5 mg bupivacaine + fentanyl 25 mcg versus hyperbaric 7.5 mg bupivacaine + fentanyl 25 mcg to lower incidence of hypotension
Timeline
- Start
- 2013-10-01
- Primary completion
- 2013-12-31
- Completion
- 2013-12-31
Publications
- Background Arzola C, Wieczorek PM. Efficacy of low-dose bupivacaine in spinal anaesthesia for Caesarean delivery: systematic review and meta-analysis. Br J Anaesth. 2011 Sep;107(3):308-18. doi: 10.1093/bja/aer200. Epub 2011 Jul 14.
- Background Rollins M, Lucero J. Overview of anesthetic considerations for Cesarean delivery. Br Med Bull. 2012;101:105-25. doi: 10.1093/bmb/ldr050. Epub 2012 Jan 4.
- Background Lee A, Ngan Kee WD, Gin T. Prophylactic ephedrine prevents hypotension during spinal anesthesia for Cesarean delivery but does not improve neonatal outcome: a quantitative systematic review. Can J Anaesth. 2002 Jun-Jul;49(6):588-99. doi: 10.1007/BF03017387.
- Background Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.
- Background Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
- Background Qiu MT, Lin FQ, Fu SK, Zhang HB, Li HH, Zhang LM, Li Q. Combination of low-dose bupivacaine and opioids provides satisfactory analgesia with less intraoperative hypotension for spinal anesthesia in cesarean section. CNS Neurosci Ther. 2012 May;18(5):426-32. doi: 10.1111/j.1755-5949.2012.00306.x.
- Background Ituk U, Habib AS. Enhanced recovery after cesarean delivery. F1000Res. 2018 Apr 27;7:F1000 Faculty Rev-513. doi: 10.12688/f1000research.13895.1. eCollection 2018.
- Background Corso E, Hind D, Beever D, Fuller G, Wilson MJ, Wrench IJ, Chambers D. Enhanced recovery after elective caesarean: a rapid review of clinical protocols, and an umbrella review of systematic reviews. BMC Pregnancy Childbirth. 2017 Mar 20;17(1):91. doi: 10.1186/s12884-017-1265-0.
- Background Leo S, Sng BL, Lim Y, Sia AT. A randomized comparison of low doses of hyperbaric bupivacaine in combined spinal-epidural anesthesia for cesarean delivery. Anesth Analg. 2009 Nov;109(5):1600-5. doi: 10.1213/ANE.0b013e3181b72d35.
- Background Ben-David B, Miller G, Gavriel R, Gurevitch A. Low-dose bupivacaine-fentanyl spinal anesthesia for cesarean delivery. Reg Anesth Pain Med. 2000 May-Jun;25(3):235-9.
- Background Ota E, Haruna M, Suzuki M, Anh DD, Tho le H, Tam NT, Thiem VD, Anh NT, Isozaki M, Shibuya K, Ariyoshi K, Murashima S, Moriuchi H, Yanai H. Maternal body mass index and gestational weight gain and their association with perinatal outcomes in Viet Nam. Bull World Health Organ. 2011 Feb 1;89(2):127-36. doi: 10.2471/BLT.10.077982. Epub 2010 Nov 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 5 mg | Intrathecal |
| Comparator | Bupivacaine | Other / unclassified | 7.5 mg | Intrathecal |
| Background | Fentanyl | Other / unclassified | 25 ug | Intrathecal |