A Prospective Randomized Double Blind Comparative Study to Determine the Efficacy of Norepinephrine and Ephedrine to Maintain Arterial Blood Pressure During Spinal Anesthesia for Cesarean Delivery
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Abstract
Background: Spinal Anesthesia Induced Hypotension(SAIH) continues to be the troublesome complication for obstetric patients undergoing cesarean section under subarachnoid block. Vasopressors are emerging as the cornerstone of treating SAIH in cesarean section patients with the evolving evidence of arterial vasodilatation as the primary cause of hypotension. This study was hypothesized to compare the efficacy of norepinephrine and ephedrine boluses to maintain hemodynamics in cesarean section.
Methods: After approval from institutional ethics committee and registration in Clinical Trials Registry India(CTRI ) and informed consent, study was conducted in 110 healthy parturients aged 18-40 years, belonging to ASA physical status I and II, posted for elective cesarean section under spinal anesthesia, were randomly allocated into group N(n=55) and group E(n=55),who received intravenous boluses of norepinephrine 6 g and ephedrine 10mg respectively as prophylaxis(one dose soon after induction) and in treatment of SAIH. The number of vasopressor boluses were recorded as primary objective and hemodynamics, APGAR scores, adverse events were noted.
Results: The number of boluses of vasopressor used was 1.9±1.2 for Ephedrine and 4.72±2.9 for Norepinephrine. At 30,40,50 and 60 minutes after anesthesia, there was significant fall in mean arterial pressure in the norepinephrine group compared to ephedrine group. The incidence of tachycardia was more in ephedrine group and incidence of bradycardia was more in norepinephrine group.
Conclusion: Both the study drugs, ephedrine and norepinephrine are comparably effective in preventing SAIH after prophylactic bolus and effective in maintaining blood pressure intraoperatively, more number of boluses of norepinephrine was required compared to ephedrine.
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[11] Sharkey AM, Siddiqui N, Downey K, Ye XY, Guevara J, Carvalho JCA. Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent and Treat Spinal-Induced Hypotension in Cesarean Deliveries: Randomized Controlled Trial. Anesth Analg. 2019; 129(5):1312-1318
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[13] Jabalameli M, Soltani HA, Hashemi J, Behdad S, Soleimani B. Prevention of post-spinal hypotension using crystalloid, colloid and ephedrine with three different combinations: A double blind randomized study. Adv Biomed Res. 2012; 1:36.
[14] Lin FQ, Qiu MT, Ding XX, Fu SK, Li Q. Ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean section: an updated meta-analysis. CNS Neurosci Ther. 2012;18(7):591-7.
[15] El Shafei MM, El Gendy HA, El Fawy DM. Norepinephrine versus ephedrine for the prevention of spinal anesthesia-induced hypotension in coronary artery disease patients undergoing knee arthroscopy. Ain-Shams J Anaesthesiol. 2015; 8(3):424-8
[16] Simin A, Zahra F, Pouya HM, Reza T. Comparison the effect of ephedrine and phenylephrine in treatment of hypotension after spinal anesthesia during cesarean section. Open J Obstet Gynecol. 2012; 2(3):192-6.
[17] Ali Elnabtity AM, Selim MF. Norepinephrine versus Ephedrine to Maintain Arterial Blood Pressure during Spinal Anesthesia for Cesarean Delivery: A Prospective Double-blinded Trial. Anesth Essays Res. 2018; 12(1):92-97.
[18] Elagamy AE, Kamaly AM, Shahin MI, et al. Norepinephrine versus ephedrine for hypotension prophylaxis during cesarean section under spinal anesthesia. Ain-Shams J Anesthesiol. 2021; 13:3.
[19] Fan QQ, Wang YH, Fu JW, Dong HL, Yang MP, Liu DD, et al. Comparison of two vasopressor protocols for preventing hypotension post-spinal anesthesia during cesarean section: a randomized controlled trial. Chin Med J (Engl). 2021; 134(7):792-9.
[20] Ngan Kee WD. A Random-allocation Graded Dose-Response Study of Norepinephrine and Phenylephrine for Treating Hypotension during Spinal Anesthesia for Cesarean Delivery. Anesthesiology. 2017; 127(6):934-41.
[21] Onwochei DN, Ngan Kee WD, Fung L, Downey K, Ye XY, Carvalho JCA. Norepinephrine Intermittent Intravenous Boluses to Prevent Hypotension During Spinal Anesthesia for Cesarean Delivery: A Sequential Allocation Dose-Finding Study. Anesth Analg. 2017; 125(1):212-218.
[22] Medlej K, Kazzi AA, El Hajj Chehade A, Saad Eldine M, Chami A, Bachir R, et al. Complications from Administration of Vasopressors Through Peripheral Venous Catheters: An Observational Study. J Emerg Med. 2018;54(1):47-53.
[23] Ngan Kee WD, Lee SWY, Ng FF, Khaw KS. Prophylactic Norepinephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery. Anesth Analg. 2018; 126(6):1989-94
[24] Xu S, Mao M, Zhang S, Qian R, Shen X, Shen J, et al. A randomized double-blind study comparing prophylactic norepinephrine and ephedrine infusion for preventing maternal spinal hypotension during elective cesarean section under spinal anesthesia: A CONSORT-compliant article. Medicine (Baltimore). 2019; 98(51):e18311.
[25] Fan QQ, Wang YH, Fu JW, Dong HL, Yang MP, Liu DD, et al. Comparison of two vasopressor protocols for preventing hypotension post-spinal anesthesia during cesarean section: a randomized controlled trial. Chin Med J (Engl). 2021; 134(7):792-9
[26] Wang X, Mao M, Liu S, Xu S, Yang J. A comparative study of bolus norepinephrine, phenylephrine, and ephedrine for the treatment of maternal hypotension in parturient with preeclampsia during caesarean delivery under spinal anaesthesia. Med Sci Monit. 2019; 25:1093-101.
[27] 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; 111(3):506-12.
[28] Minzter BH, Johnson RF, Paschall RL, Ramasubramanian R, Ayers GD, Downing JW. The diverse effects of vasopressors on the fetoplacental circulation of the dual perfused human placenta. Anesth Analg. 2010; 110(3): 857-62.
[29] Ngan Kee WD, Lee SWY, Ng FF, Le A. Norepinephrine or phenylephrine during spinal anaesthesia for Caesarean delivery: a randomised double-blind pragmatic non-inferiority study of neonatal outcome. Br J Anaesth. 2020; 125:588-595.
[2] Cook TM, Counsell D, Wildsmith JA. Royal College of Anaesthetists Third National Audit Project. Major complications of central neuraxial block: report on the Third National Audit Project of the Royal College of Anaesthetists. Br J Anaesth. 2009; 102(2):179-90.
[3] Montoya B, Oliveros C, Moreno M, Diego A. Managing hypotension induced by spinal anesthesia for caesarean section. Rev Colomb Anestesiol. 2009; 37(2):131-40.
[4] Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, et al. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2020; 7(7).
[5] Ryu C, Choi GJ, Park YH, Kang H. Vasopressors for the management of maternal hypotension during cesarean section under spinal anesthesia: A Systematic review and network meta-analysis protocol. Medicine. 2019; 98(1):e13947.
[6] Heesen M, Hilber N, Rijs K, Rossaint R, Girard T, Mercier FJ, et al. A systematic review of phenylephrine vs. noradrenaline for the management of hypotension associated with neuraxial anaesthesia in women undergoing caesarean section. Anaesthesia. 2020; 75:800-8.
[7] Puthenveettil N, Sivachalam SN, Rajan S, Paul J, Kumar L. Comparison of norepinephrine and phenylephrine boluses for the treatment of hypotension during spinal anaesthesia for caesarean section - A randomised controlled trial. Indian J Anaesth. 2019; 63(12):995-1000.
[8] Ngan Kee WD, Lee SW, Ng FF, Tan PE, Khaw KS. Randomized double-blinded comparison of norepinephrine and phenylephrine for maintenance of blood pressure during spinal anesthesia for cesarean delivery. Anesthesiology. 2015; 122(4):736-45.
[9] Hasanin AM, Amin SM, Agiza NA. Norepinephrine infusion for preventing postspinal anesthesia hypotension during cesarean delivery: a randomized dose-finding trial. Anesthesiology. 2019;130(1):55–62.
[10] Nathan N, Wong CA. Spinal, Epidural, and Caudal Anesthesia; Anatomy, Physiology, and Technique In: Chestnut DH, Wong AC, Tsen LC, Ngan Kee WD, Beilin Y, Mhyre JM, Bateman BT. Chestnut’s obstetric anesthesia: Principles and practice. 6th ed. Philadelphia: Elsevier; 2020.p.240-44
[11] Sharkey AM, Siddiqui N, Downey K, Ye XY, Guevara J, Carvalho JCA. Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent and Treat Spinal-Induced Hypotension in Cesarean Deliveries: Randomized Controlled Trial. Anesth Analg. 2019; 129(5):1312-1318
[12] Shah PJ, Agrawal P, Beldar RK. Intravenous norepinephrine and mephentermine for maintenance of blood pressure during spinal anaesthesia for caesarean section: An interventional double-blinded randomised trial. Indian J Anaesth. 2020; 64(Suppl 4):235-41.
[13] Jabalameli M, Soltani HA, Hashemi J, Behdad S, Soleimani B. Prevention of post-spinal hypotension using crystalloid, colloid and ephedrine with three different combinations: A double blind randomized study. Adv Biomed Res. 2012; 1:36.
[14] Lin FQ, Qiu MT, Ding XX, Fu SK, Li Q. Ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean section: an updated meta-analysis. CNS Neurosci Ther. 2012;18(7):591-7.
[15] El Shafei MM, El Gendy HA, El Fawy DM. Norepinephrine versus ephedrine for the prevention of spinal anesthesia-induced hypotension in coronary artery disease patients undergoing knee arthroscopy. Ain-Shams J Anaesthesiol. 2015; 8(3):424-8
[16] Simin A, Zahra F, Pouya HM, Reza T. Comparison the effect of ephedrine and phenylephrine in treatment of hypotension after spinal anesthesia during cesarean section. Open J Obstet Gynecol. 2012; 2(3):192-6.
[17] Ali Elnabtity AM, Selim MF. Norepinephrine versus Ephedrine to Maintain Arterial Blood Pressure during Spinal Anesthesia for Cesarean Delivery: A Prospective Double-blinded Trial. Anesth Essays Res. 2018; 12(1):92-97.
[18] Elagamy AE, Kamaly AM, Shahin MI, et al. Norepinephrine versus ephedrine for hypotension prophylaxis during cesarean section under spinal anesthesia. Ain-Shams J Anesthesiol. 2021; 13:3.
[19] Fan QQ, Wang YH, Fu JW, Dong HL, Yang MP, Liu DD, et al. Comparison of two vasopressor protocols for preventing hypotension post-spinal anesthesia during cesarean section: a randomized controlled trial. Chin Med J (Engl). 2021; 134(7):792-9.
[20] Ngan Kee WD. A Random-allocation Graded Dose-Response Study of Norepinephrine and Phenylephrine for Treating Hypotension during Spinal Anesthesia for Cesarean Delivery. Anesthesiology. 2017; 127(6):934-41.
[21] Onwochei DN, Ngan Kee WD, Fung L, Downey K, Ye XY, Carvalho JCA. Norepinephrine Intermittent Intravenous Boluses to Prevent Hypotension During Spinal Anesthesia for Cesarean Delivery: A Sequential Allocation Dose-Finding Study. Anesth Analg. 2017; 125(1):212-218.
[22] Medlej K, Kazzi AA, El Hajj Chehade A, Saad Eldine M, Chami A, Bachir R, et al. Complications from Administration of Vasopressors Through Peripheral Venous Catheters: An Observational Study. J Emerg Med. 2018;54(1):47-53.
[23] Ngan Kee WD, Lee SWY, Ng FF, Khaw KS. Prophylactic Norepinephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery. Anesth Analg. 2018; 126(6):1989-94
[24] Xu S, Mao M, Zhang S, Qian R, Shen X, Shen J, et al. A randomized double-blind study comparing prophylactic norepinephrine and ephedrine infusion for preventing maternal spinal hypotension during elective cesarean section under spinal anesthesia: A CONSORT-compliant article. Medicine (Baltimore). 2019; 98(51):e18311.
[25] Fan QQ, Wang YH, Fu JW, Dong HL, Yang MP, Liu DD, et al. Comparison of two vasopressor protocols for preventing hypotension post-spinal anesthesia during cesarean section: a randomized controlled trial. Chin Med J (Engl). 2021; 134(7):792-9
[26] Wang X, Mao M, Liu S, Xu S, Yang J. A comparative study of bolus norepinephrine, phenylephrine, and ephedrine for the treatment of maternal hypotension in parturient with preeclampsia during caesarean delivery under spinal anaesthesia. Med Sci Monit. 2019; 25:1093-101.
[27] 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; 111(3):506-12.
[28] Minzter BH, Johnson RF, Paschall RL, Ramasubramanian R, Ayers GD, Downing JW. The diverse effects of vasopressors on the fetoplacental circulation of the dual perfused human placenta. Anesth Analg. 2010; 110(3): 857-62.
[29] Ngan Kee WD, Lee SWY, Ng FF, Le A. Norepinephrine or phenylephrine during spinal anaesthesia for Caesarean delivery: a randomised double-blind pragmatic non-inferiority study of neonatal outcome. Br J Anaesth. 2020; 125:588-595.
| Files | ||
| Issue | Vol 9 No Supp. 2 (2023): Supplement 2 |
|
| Section | Research Article(s) | |
| DOI | https://doi.org/10.18502/aacc.v9i6.14450 | |
| Keywords | ||
| Spinal hypotension Ephedrine Norepinephrine Cesarean section | ||
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How to Cite
1.
Sannaboraiah S, Rajegowda S. A Prospective Randomized Double Blind Comparative Study to Determine the Efficacy of Norepinephrine and Ephedrine to Maintain Arterial Blood Pressure During Spinal Anesthesia for Cesarean Delivery. Arch Anesth & Crit Care. 2023;9(Supp. 2):522-529.
