The influence of intravenous ondansetron on maternal blood haemodynamics after spinal anaesthesia for caesarean section: a double-blind, placebo-controlled study

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(1)Ginekol Pol. 2015, 86, 461-467. DOI: 10.17772/gp/2405. P R A C E. O R Y G I N A L N E po ł o ż n i c t wo. The influence of intravenous ondansetron on maternal blood haemodynamics after spinal anaesthesia for caesarean section: a double-blind, placebo-controlled study Wpływ ondansetronu na parametry hemodynamiczne matki podczas znieczulenia podpajęczynówkowego do cięcia cesarskiego – badanie randomizowane, przeprowadzone metodą podwójnie ślepej próby

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(4) 1 2 1 1 2. Department of Anaesthesiology and Intensive Therapy, Medical University of Gdansk, Poland Department of Obstetrics, Medical University of Gdansk, Poland. Abstract Objective: verification of a hypothesis assuming that 5-HT3 receptor blockade by intravenous administration of ondansetron reduces the incidence of hypotension and bradycardia in patients undergoing spinal anaesthesia for Caesarean section. Material and methods: The study design was approved by the Bioethics Committee and included 72 patients undergoing elective Caesarean section, randomly assigned to ondansetron group (group O) or placebo group (group P). Finally, group O encompassed 35 patients administered ondansetron 8 mg i.v. dissolved in 10ml 0.9% NaCl whereas group P consisted of 34 patients receiving 0.9% NaCl 10 mg. Systolic and diastolic pressures were measured every 2 minutes since the onset of anaesthesia. Heart rate (HR) was monitored continuously. The criterion of hypotension requiring ephedrine was a decrease in systolic pressure by 20% compared to its baseline value or a decrease in systolic pressure below 90 mm Hg. The criterion of bradycardia was a decrease in HR below 60/min. Results: Hypotension was observed in 14 group O patients (39%) and in 15 group P patients (44%); the difference was not statistically significant. Bradycardia was noted in 1 group O patient (3%) and in 2 group P patients (6%); the difference was not statistically significant. Conclusion: A hypothesis assuming a reduction in pressure following subarachnoid anaesthesia for Caesarean section after the administration of 8 mg of ondansetron was not confirmed.. Key words: / spinal anaesthesia / caesarean section / hypotension /. Corresponding author: Andrzej Marciniak Department of Anaesthesiology and Intensive Therapy, Medical University of Gdansk Poland, 80-214 Gdansk, Smoluchowskiego 17 ph.:+48 58 349 32 7 fax.: +48 58 349 32 90 e-mail: amarcin@gumed.edu.pl. Nr 6/2015. © Polskie Towarzystwo Ginekologiczne. Otrzymano: 12.11.2014 Zaakceptowano do druku: 15.01.2015. 461.

(5) P R A C E O R Y G I N A L N E poł ożn i ct wo. DOI: 10.17772/gp/2405. Ginekol Pol. 2015, 86, 461-467. Andrzej Marciniak et al. The influence of intravenous ondansetron on maternal blood haemodynamics after spinal anaesthesia for caesarean section.... Streszczenie Cel pracy: weryfikacja hipotezy zakładającej, że blokada receptorów 5-HT3 poprzez dożylne podanie ondansetronu redukuje częstość występowania hipotensji i bradykardii u pacjentek znieczulanych podpajęczynówkowo do cięcia cesarskiego. Materiał i metodyka: Plan badań uzyskał zgodę komisji bioetycznej. Do badania zakwalifikowano 72 pacjentki poddawane planowemu cięciu cesarskiemu, losowo przydzielając je do grupy ondansetronu (grupa O) lub grupy placebo (grupa P). Ostatecznie grupa O liczyła 36 pacjentek, którym przed znieczuleniem podano dożylnie 8 mg ondansetronu rozcieńczonego w 10 ml 0,9% NaCl, grupa P liczyła 34 pacjentki, które otrzymały 10 ml 0,9% NaCl. Pomiaru skurczowego i rozkurczowego ciśnienia tętniczego krwi dokonywano co 2 minuty od momentu znieczulenia. Częstość akcji serca (HR) monitorowana była w sposób ciągły. Za kryterium hipotensji wymagającej podania efedryny przyjęto spadek ciśnienia skurczowego o 20% w porównaniu z ciśnieniem wyjściowym lub spadek ciśnienia skurczowego poniżej 90 mm Hg. Za kryterium bradykardii przyjęto spadek akcji serca poniżej 60/min. Wyniki: Hipotensję zanotowano u 14 pacjentek w grupie O (39%) i u 15 pacjentek w grupie P (44%) co nie stanowiło statystycznie istotnej różnicy. Bradykardię zanotowano u 1 pacjentki w grupie O (3%) i u 2 pacjentek w grupie P (6%) co nie stanowiło statystycznie istotnej różnicy. Wnioski: Nie potwierdzono przyjętej hipotezy zakładającej redukcję spadku ciśnienia po znieczuleniu podpajęczynówkowym do cięcia cesarskiego po podaniu 8 mg Ondansetronu.. Słowa kluczowe: /

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(333) P R A C E O R Y G I N A L N E poł ożn i ct wo. Ginekol Pol. 2015, 86, 461-467. DOI: 10.17772/gp/2405. Andrzej Marciniak et al. The influence of intravenous ondansetron on maternal blood haemodynamics after spinal anaesthesia for caesarean section.... Tabl e I . Demographic, obstetric and surgical data. a.

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(336) . . . . . . . . !". . . . . . . # $ % . & . a. Data are presented as the mean ± SD. Tabl e I I . Surgical data.. Figure 1. The blockade distribution of the number of anesthetised segments above S1. Data includes the means and 95% confidence intervals. a – P < 0.0005 when compared with the baseline values..

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(344) . p. Figure 2. The systolic arterial pressure over time. The maternal systolic pressure was measured over sixteen minutes following spinal anaesthesia in Groups O and P. a – P < 0.01 when compared with the (-30) min. group O value; b – P < 0.0005 when compared with the (-30) min. group O value; c – P < 0.05 when compared with the (-30) min. group O value.. Data are presented as medians (min-max) Data are presented as means ± SD. Tabl e I V. Side effects.

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(347) ,$ . 0. 0. . 4++. 0. 0. . Data are presented as n (%). 464. c b. Figure 3. The diastolic arterial pressure over time. The maternal systolic pressures were measured over sixteen minutes following spinal anaesthesia in Groups O and P. a – P < 0.0005 when compared with the (-30) min. group O value; b – P < 0.005 when compared with the (-30) min. group O value; c – P < 0.05 when compared with the (-30) min. group O value.. © Polskie Towarzystwo Ginekologiczne. Nr 6/2015.

(348) Ginekol Pol. 2015, 86, 461-467. P R A C E. DOI: 10.17772/gp/2405. O R Y G I N A L N E po ł o ż n i c t wo. Andrzej Marciniak et al. The influence of intravenous ondansetron on maternal blood haemodynamics after spinal anaesthesia for caesarean section.... 110. 85. 105 80. 100 95. 75. 90 70. 85 DV_1. mm Hg. 80 75. 65. a a. 60. 70 65. d. 60. a b. 55. 55. a c. 50. 50 45. 45. MAP(-30) MAP-2 MAP-6 MAP-10 MAP-14 MAP-0 MAP-4 MAP-8 MAP-12 MAP-16. DAP(-30). group O group P. Figure 4. The mean arterial pressure over time. The maternal systolic pressures were measured for sixteen minutes following spinal anaesthesia in Groups O and P. a – P < 0.05 when compared with the (-30) min. group O value; b – P < 0.001 when compared with the (-30) min. group O value; c – P < 0.0005 when compared with the 0 min. group O value; d – P < 0.05 when compared with the 8 min. group O value.. grupa O grupa P. Figure 7. The initial and minimal DAP value comparisons during the study. a – P < 0.0005 when compared with the (-30) min. SAP value in the same group.. 130. 100. 95. 110. 90 MAP value (mm Hg). 120. 100. min-1. min DAP. a 90. b. 80. 85. 80. !. 75. !. b b. 70. 70. b. 65. 60. 60. 50. HR(-30). HR-2 HR-0. HR-6 HR-4. HR-10 HR-8. MAP(-30). HR-14 HR-12. HR-16. group O group P. Figure 5. The changes in heart rate during the study. a – P < 0.0005 when compared with the (-30) min. group O value; b – P < 0.05 when compared with the 2 min. group O value.. 125 120. DAP value (mm Hg). 115. a. a. 105 100. Figure 8. The initial and minimal MAP value comparisons during the study. a – P < 0.0005 when compared with the (-30) min. SAP value in the same group.. Discussion. 95 90 85 SAP(-30). min SAP. Figure 6. The initial and minimal SAP value comparisons during the study. a – P < 0.0005 when compared with the (-30) min SAP value in the same group.. Nr 6/2015. R1. grupa O grupa P. 6% $3 ); )= %#

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(511) # . Oświadczenie autorów: 1. Andrzej Marciniak - współautor koncepcji i założeń pracy, przygotowanie manuskryptu i piśmiennictwa, zebranie materiału – autor zgłaszający i odpowiedzialny za manuskrypt. 2. Radosław Owczuk – współautor koncepcji i założeń pracy, analiza statystyczna wyników, korekta manuskryptu. 3. Maria Wujtewicz– ostateczna weryfikacja i akceptacja manuskryptu, współautor protokołu, korekta i aktualizacja literatury. 4. Krzysztof Preis – korekta i akceptacja ostatecznego kształtu manuskryptu. 5. Katarzyna Majdyło – pomoc w zebraniu materiału. Źródło finansowania: Praca nie była finansowana przez żadną instytucję naukowo-badawczą, stowarzyszenie ani inny podmiot, autorzy nie otrzymali żadnego grantu. Konflikt interesów: Autorzy nie zgłaszają konfliktu interesów oraz nie otrzymali żadnego wynagrodzenia związanego z powstawaniem pracy.. References 1. Stasiełuk A, Langowicz I, Kosińska-Kaczyńska K, [et al.]. Czy epidemia cięć cesarskich jest wykładnikiem liberalizacji wskazań? Ginekol Pol. 2012, 83, 604-608. 2.. Skręt-Margieło J, Barnaś E, Sęk-Kłębukowska B, [et al.]. Intracranial hematoma as the cause of headache after subarachnoid anesthesia for cesarean section – a case report. Ginekol Pol. 2014, 85, 58-61.. 3. Corke BC, Datta S, Ostheimer GW, [et al.]. Spinal anaesthesia for Caesarean section. The influence of hypotension on neonatal outcome. Anesthesia. 1982, 37 (6), 658–662. 4. Carpenter RL, Caplan RA, Brown DL, [et al.]. Incidence and risk factors for side effects of spinal anesthesia. Anesthesiology. 1992, 76 906–916. 5. French GW, White JB, Howell SJ, Popat M. Comparsion of pentastarch and Hartmann’s solution for volume preloading in spinal anaesthesia for elective cesarean section. Br J Anasth. 1999, 83, 475–477. 6. Riley ET, Editorial I. Spinal anaesthesia for caesarean delivery keep the pressure up and don’t spare the vasoconstrictors. Br J Anaesth. 2004, 92 (4), 459-461.. © Polskie Towarzystwo Ginekologiczne. Nr 6/2015.

(512) Ginekol Pol. 2015, 86, 461-467. DOI: 10.17772/gp/2405. P R A C E. O R Y G I N A L N E po ł o ż n i c t wo. Andrzej Marciniak et al. The influence of intravenous ondansetron on maternal blood haemodynamics after spinal anaesthesia for caesarean section... K O M U N I K A T. 7. Somboonviboon W, Kyokong O, Charuluxananan S, Narasethakamol A. Incidence and risk factors of hypotension and bradycardia after spinal anesthesia for cesarean section. J Med Assoc Thai. 2008, 91 (2), 181-187. 8. Liu SS, McDonald SB. Current issues in spinal anesthesia. Anesthesiology. 2001, 94, 888-906. 9. Campagna JA, Carter C. Clinical relevance of the Bezold-Jarisch reflex. Anesthesiology. 2003, 98, 1250-1260. 10. Aviado DM, Guevara Aviado D. The Bezold-Jarisch reflex. A historical perspective of cardiopulmonary reflexes. Ann N Y Acad Sci. 2001, 940, 48-58. 11. Mao HZ, Li Z, Chapleau MW. Platelet activation in carotid sinuses triggers reflex sympathoinhibition and hypotension. Hypertension. 1996, 27 (3 Pt 2), 584-590. 12. Leaños OL, Hong E, Amezcua JL. Reflex circulatory collapse following intrapulmonary entrapment of activated platelets: mediation via 5-HT3 receptor stimulation. Br J Pharmacol. 1995, 116 (3), 2048-2052. 13. Yamano M, Ito H, Kamato T, Miyata K. Characteristics of inhibitory effects of serotonin (5-HT)3receptor antagonists, YM060 and YM114 (KAE-393), on the von Bezold-Jarisch reflex induced by 2-Methyl-5-HT, veratridine and electrical stimulation of vagus nerves in anesthetized rats. Jpn J Pharmacol. 1995, 69 (4), 351-356. 14. Owczuk R, Wenski W, Polak-Krzeminska A, [et al.]. Ondansetron given intravenously attenuates arterial blood pressure drop due to spinal anesthesia: a double-blind, placebo-controlled study. Reg Anesth Pain Med. 2008, 33 (4), 332-339. 15. Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: A double-blind randomised, placebocontrolled study. Int J Obstet Anesth. 2012, 21, 24–28. 16. Macarthur A. Solving the problem of spinal-induced hypotension in obstetric anesthesia. Can J Anaesth. 2002, 49 (6), 536-539. 17. Cyna AM, Andrew M, Emmett RS, [et al.]. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Review. Cochrane Database of Systematic Reviews 2009, Issue 1. 18. Practice Guidelines for obstetric anesthesia. An updated report by the American Society of Anesthesiologists task Force on Obstetric Anesthesia. Anesthesiology. 2007, 106, 843-863. 19. Marciniak A, Wujtewicz M, Owczuk R. The impact of colloid infusion prior to spinal anaesthesia for caesarean section on the condition of a newborn - a comparison of balanced and unbalanced hydroxyethyl starch 130/0.4 Anaesth Int Ther. 2013, 45 (1), 14–19. 20. Litke J, Pikulska A,Wegner T. Management of perioperative stress in children and parents. Part II — anaesthesia and postoperative period. Anaesth Int Ther. 2012, 44 (2), 170–174. 21. Song JW, Park EY, Lee YG, [et al.]. The effect of combining dexamethasone with ondansetron for nausea and vomiting associated with fentanyl-based intravenous patient-controlled analgesia. Anaesthesia. 2011, 66, 263–267.. Warunki prenumeraty

(513) . !" # "$. % ! ! ! . &!! ' ( ! ) ! . ! ! * ) * !! ) !. +! # $' * *. . ! * ! * * &!! * ' , - . . ! ). !"* . /012 3 14000 56' 789'. 22. Carlisle JB. A meta-analysis of prevention of postoperative nausea and vomiting: randomised controlled trials by Fujii et al. compared with other authors. Anaesthesia. 2012, 67, 1076–1090. 23. Pollard JB. Cardiac arrest during spinal anesthesia: common mechanisms and strategies for prevention. Anesth Analg. 2001, 92 (1), 252-256. 24. Yamano M, Kamato T, Nishida A, [et al.]. Serotonin (5-HT)3-receptor antagonism of 4,5,6,7-tetrahydrobenzimidazole derivatives against 5-HT-induced bradycardia in anesthetized rats. Jpn J Pharmacol. 1994, 65 (3), 241-248. 25. White CM, Chow MS, Fan C, [et al.]. Efficacy of intravenous granisetron in suppressing the bradycardia and hypotension associated with a rabbit model of the Bezold-Jarisch reflex. J Clin Pharmacol. 1998, 38 (2), 172-177. 26. Tsikouris JP, Kluger J, Chow MS, White CM. Usefulness of intravenous granisetron for prevention of neurally mediated hypotension upon head upright tilt testing. Am J Cardiol. 2000, 85 (10), 1262-1264. 27. Klöhr S, Roth R, Hofmann T, [et al.]. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010, 54 (8), 909-921. 28. King TS, Steger RW, Morgan WW. Effect of ovarian steroids to stimulate region-specific hypothalamic 5-hydroxytryptamine synthesis in ovariectomized rats. Neuroendocrinology. 1986, 42 (4), 344-350. 29. Raap DK, DonCarlos L, Garcia F, [et al.]. Estrogen desensitizes 5-HT(1A) receptors and reduces levels of G(z), G(i1) and G(i3) proteins in the hypothalamus Neuropharmacology. 2000, 39 (10), 1823-1832. 30. Aggarwal M, Puri V, Puri S. Effects of estrogen on the serotonergic system and calcitonin generelated peptide in trigeminal ganglia of rats Ann Neurosci. 2012, 19 (4),151-157. 31. Gall V, Kosec V, Vranes HS, [et al.]. Platelet serotonin concentration at term pregnancy and after birth: physiologic values for Croatian population. Coll Antropol. 2011, 35 (3), 715-718. 32. Carrasco G, Cruz MA, Gallardo V, Miguel P, [et al.]. Plasma and platelet concentration and platelet uptake of serotonin in normal and pre-eclamptic pregnancies. Life Sci. 1998, 62 (15), 1323-1332.. :) " ! ! ;. !3. +! # $ < = > ?0@2A2 > ' AA ' 3 7?1 4B@1C@/?2

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