Randomized clinical trial comparing oral prednisone (50 mg) with placebo before laparoscopic cholecystectomy
Tóm tắt
Intravenous administration of dexamethasone 90 min before laparoscopic cholecystectomy improves surgical outcome but may be impractical. The objective of this study was to assess the clinical efficacy of oral self-administration of prednisone 2 h before ambulatory laparoscopic cholecystectomy. In a double-blind placebo-controlled study, 200 patients were randomized to oral administration of prednisone (50 mg) or placebo 2 h before laparoscopic cholecystectomy. Patients received a similar standardized anaesthetic, surgical, and analgesic treatment. The primary outcome was pain 24 h after surgery and secondary outcomes were fatigue and malaise 24 h after surgery. Outcome parameters were registered before operation, on the day of operation, and the following two days. Analgesic and antiemetic requirements were registered, and nausea and vomiting were assessed twice within the first 24 h. Side-effects and 30-day follow-up for morbidity were registered. Data from 184 patients were available for statistical analysis. There were no significant differences in side-effects or complications between the surgical groups (P > 0.05). No significant intergroup differences in 24-h pain, fatigue or malaise scores or any other variables were found (P > 0.05). There is no important clinical gain of preoperative oral steroid administration compared with placebo in patients undergoing laparoscopic cholecystectomy.
Tài liệu tham khảo
Bisgaard T, Klarskov B, Kehlet H, Rosenberg J (2003) Preoperative dexamethasone improves surgical outcome after laparoscopic cholecystectomy. A randomized double-blind placebo-controlled trial Ann Surg 238:651–660
Bisgaard T, Klarskov B, Rosenberg J, Kehlet H (2001) Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain 90:261–69
Bisgaard T, Klarskov B, Rosenberg J, Kehlet H (2001) Factors determining convalescence after uncomplicated laparoscopic cholecystectomy. Arch Surg 136:917–21
Bisgaard T, Kristiansen VB, Hjortsø NC, Jacobsen LS, Rosenberg J, Kehlet H (2004) Randomised clinical trial comparing an oral carbohydrate beverage with placebo before laparoscopic cholecystectomy. Br J Surg 91:151–158
Bisgaard T (2006) Analgesic treatment after laparoscopic cholecystectomy. A critical assessment of the evidence. Anesthesiology 104:835–846
Callery MP (2003) Preoperative steroids for laparoscopic surgery. Ann Surg 238:661–662
Coloma M, White PF, Markowitz SC, Whitten CW, Macaluso AR, Berrisford SB, Thornton KC (2002) Dexamethasone in combination with dolasetron for prophylaxis in the ambulatory setting. Effect on outcome after laparoscopic cholecystectomy. Anesthesiology 96:1346–50
DiSanto AR, DeSante KA (1975) Bioavailability and pharmacokinetics of prednisone in humans. J Pharma Sci 64:109–112
Egger M, Juni P, Bartlett C, for the Consort Group (2001) The Value of patient flow charts in reports of randomized controlled trials: Bibliography study. JAMA 285:1996–1999
Feo CV, Sortini D, Ragazzi R, De Palma M, Liboni A (2006) Randomized clinical trial of the effect of preoperative dexamethasone on nausea and vomiting after laparoscopic cholecystectomy. Br J Surg 93:295–299
Ferry JJ, Horvath AM, Bekersky I, Heath EC, Ryan CF, Colburn WA (1988) Relative and absolute bioavailability of prednisone and prednisolone after separate oral and intravenous doses. J Clin Pharmacol 28:81–87
Fujii Y, Saitoh Y, Tanaka H, Toyooka H (2000) Granisetron/dexamethasone combination for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. Eur J Anaesthesiol 17:64–68
Gambertoglio JG, Frey FJ, Holford NHG, Birnbaum JL, Lizak PS, Vincenti F, Feduska NJ, Salvatierra O, Amend WJC (1982) Prednisone and prednisolone bioavailability in renal transplant patients. Kidney Int 21:621–626
Garg V, Jusko WJ (1994) Bioavailability, reversible metabolism of prednisone and prednisolone in man. Biopharm Drug Dispos 15:163–172
Greif R, Laciny S, Rapf B, Hickle RS, Sessler DI (1999) Supplemental oxygen reduces the incidence of postoperative nausea and vomiting. Anesthesiology 91:1246–52
Holte K, Kehlet H ( 2002) Perioperative single dose glucocorticoid administration - pathophysiological effects and clinical implications. J Am Coll Surg 195:694–712
Leksowski K, Peryga P, Szyca R (2006) Ondansetron, metoclopramid, dexamethason, and their combinations compared for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: A prospective randomized study. Surg Endosc 20:878–878
Morrow SA, Stoian CA, Dmitrovic J, Chan SC, Metz LM (2004) The bioavailability of IV methyldprednisolone and oral prednisone in multiple sclerosis. Neurology 63:1079–1080
Pickup ME (1979) Clinical pharmacokinetics of prednisone and prednisolone. Clin Pharmacokin 4:111–128
Sapolsky RM, Romero LM, Munck AU (2000) How do glucocorticoids influence stress responses? Integrating permissive, suppressive, stimulatory, and preparative actions. Endocr Rev 21:55–89
Schwartz JI, Mukhopadhyay S, Porras AG, Viswanathan-Aiyer KJ, Adcock S, Ebel DL, Gertz BJ (2003) Effect of rofecoxib on prednisolone and prednisone in pharmacokinetics in healthy subject. J Clin Pharmacol 43:187–192
Wang JJ, Ho ST, Liu YH, Lee SC, Liu YC, Liao YC (1999) Dexamethasone reduces nausea and vomiting after laparoscopic cholecystectomy. Br J Anaesth 83:772–75
Wang JJ, Ho ST, Tzeng JI, Tang CS (2000) The effect of timing of dexamethasone administration on its efficacy as a prophylactic antiemetic for postoperative nausea and vomiting. Anesth Analg 91:136–39
Wang JJ, Ho ST, Uen YH, Lin MT, Chen KT, Huang JC (2002) Small-dose dexamethasone reduces nausea and vomiting after laparoscopic cholecystectomy: a comparison of tropisetron with saline. Anesth Analg 95:229–32