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Intravenous Infusion Versus Intrathecal Injection of Magnesium Sulfate for Prevention of Postspinal Shivering During Lower Limb Fracture Surgery. A Randomized Comparative Study
Sponsor study identifier
interventional
90
1 country
1
Study Start
January 15, 2020
Actual (reported)Primary Completion
June 1, 2020
Actual (reported)Study Completion
June 3, 2020
Actual (reported)Shivering is an unpleasant experience after spinal anesthesia. Shivering is defined as an involuntary, repetitive activity of skeletal muscles. The mechanisms of shivering in patients undergoing surgery are mainly intraoperative heat loss, increased sympathetic tone, pain, and systemic release of pyrogens. Spinal anesthesia significantly impairs the thermoregulation system by inhibiting tonic vasoconstriction, which plays a significant role in temperature regulation. Spinal anesthesia also causes redistribution of core heat from the trunk (below the block level) to the peripheral tissues. These two effects predispose patients to hypothermia and shivering. The median incidence of shivering related to regional anesthesia observed in a review of 21 studies is 64.4%. Shivering increases oxygen consumption, lactic acidosis, carbon dioxide production, and metabolic rate by up to 400%. Therefore, shivering may cause problems in patients with low cardiac and pulmonary reserves. The best way to avoid these intraoperative and postoperative shivering-induced increases in hemodynamic and metabolic demands is to prevent shivering in the first place. Although magnesium is among several pharmacological agents used for the treatment of shivering, its effects on prevention of shivering during central neuraxial blockade have not been evaluated to date. Henceforth, the aim of this study was to evaluate the effect of magnesiume on shivering during spinal anesthesia. Aim: to compare the efficacy of intravenous versus intrathecal magnesium sulphate for prevention of post spinal shivering in adult patients undergoing elective lower limb orthopedic surgeries.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 3, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 15, 2020
Actual (reported)January 28, 2020
Actual (reported)January 31, 2020
Actual (reported)June 1, 2020
Actual (reported)June 3, 2020
Actual (reported)incidence of postspinal shivering
the efficacy of the use of MgSo4 IV infusion versus intrathecal injection in decreasing the incidence of postspinal shivering using Crossley and Mahajan scale which is 0, no shivering; 1, piloerection or peripheral vasoconstriction (cyanosis) but no visible shivering; 2, muscular activity in only one muscle group; 3, muscular activity in more than one muscle group but not generalized shivering; and 4, shivering involving the whole body
up to 5 months
45 patients will receive 50 mg intrathecal MgSo4 added to 0.5% hyperbaric bupivacaine
45 patients will receive IV magnesium sulfate 50 mg/kg in 100 mL isotonic saline over 20 min as a bolus then 2 mg/kg/h infusion using a separate infusion set after administering spinal anesthesia
0.5% heavy bupivacaine in the spinal with no additives
intrathecal versus IV infusion of Magnesium sulfate for prevention of postspinal shivering
anesthesia department at Cairo University
Cairo, Elmanial, 11562, Egypt
1. Frank S.M., Higgins M.S., Breslow M.J., et al. The catecholamine, cortisol, and hemodynamic responses to mild perioperative hypothermia: a randomized clinical trial Anesthesiology,1995, 82:83-93. 2. Crowley LJ, Buggy DJ .Shivering and neuraxial anesthesia.Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006. 3. Mizobe T., Nakajima Y., Sunaguchi M., et al.Clonidine produces a dose-dependant impairment of baroreflex-mediated thermoregulatory responses to positive end-expiratory pressure in anesthetized humans.BJA, 2005, 94:536-541 4. Witte J. De, Sessler D.I.Perioperative shivering: physiology and pharmacology.Anesthesiology, 2002,96:467-484 5. Eberhart LH, Döderlein F, Eisenhardt G, et al Independent risk factors for postoperative shivering. Anesth Analg,2005, 101:1849-1857. 6. Lyons B, Power C, Casey W.Postanaesthesia shivering in children. Anaesthesia 1996.51: 442-445. 7. Hull D, Smales . Heat production in the newborn. In: Sinclair JC (eds.) Temperature Regulation and Energy Metabolism in the Newborn. Grune& Stratton, New York.1978 46:129-156 8. Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia 1994,49:205-207 9. P. Kranke, L.H. Eberhart, N. Roewer, M.R. TramerSingle-dose parenteral pharmacological interventions for the prevention of postoperative shivering: a quantitative systematic review of randomized controlled trials Anesth Analg, 2004, 99 :718-727 10. T. Ikeda, T. Kazama, D.I. Sessler, et al.Induction of anesthesia with ketamine reduces the magnitude of redistribution hypothermia.Anesth Analg, 2001,93: 934-938 11. S. Kizilirmak, S.E. Karakas, O. Akca, et al.Magnesium sulfate stops postanesthetic shivering.Ann NY Acad Sci, 1997813: 799-806 12. R.M. Zweifler, M.E. Voorhees, M.A. Mahmood, M. Parnell.Magnesium sulfate increases the rate of hypothermia via surface cooling and improves comfort.Stroke, 2004,35:2331-2334 13. D.B. Cotton, M. Hallak, C. Janusz, S.M. Irtenkauf, R.F. BermanCentral anticonvulsant effects of magnesium sulfate on N-methyl-D-aspartate-induced seizures.Am J Obstet Gynecol, 1993,168:974-978 14. C. Lee, X. Zhang, W.F. Kwan.Electromyographic and mechanomyographic characteristics of neuromuscular block by magnesium sulphate in the pig.Br J Anaesth, 1996,76:278-283 15. V. Rukshin, P.K. Shah, B. Cercek, A. Finkelstein, V. Tsang, S. Kaul.Comparative antithrombotic effects of magnesium sulfate and the platelet glycoprotein IIb/IIIa inhibitors tirofiban and eptifibatide in a canine model of stent thrombosis.Circulation, 2002,105:1970-1975 16. Gozdemir M, Usta B, Demircioglu RI, Muslu B, Sert H, Karatas OF. Magnesium sulfate infusion prevents shivering during transurethral prostatectomy with spinal anesthesia: a randomized, double-blinded, controlled study. J Clin Anesth. 2010,22:184-189.
90 participants (actual enrollment reported by the registry).
First Submitted
Contact the study team to confirm eligibility.
January 28, 2020
First Posted
January 31, 2020
Study Start
January 15, 2020
Actual (reported)Primary Completion
June 1, 2020
Actual (reported)Study Completion
June 3, 2020
Actual (reported)Last Updated
August 6, 2020
Record last verified: 2020-08
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