Abstract
Background
Endoscopy under midazolam sedation requires a 2-h recovery facility.
Aim
To study the potential of shortening patients’ stay without jeopardizing patients’ safety by the use of the benzodiazepine-antagonist flumazenil in the everyday practice and to investigate the feasibility of a study comparing midazolam with recovery with midazolam–flumazenil and immediate discharge.
Methods
Consecutive ambulatory patients referred for endoscopy under midazolam sedation with ASA I or II, escorted by a person, were eligible. Flumazenil was given on arrival in the recovery room. Patients were discharged when adequate Aldrete scores and physical mobility were present. The next day, they were contacted by telephone.
Results
A total of 1,506 patients participated. They received 5 mg midazolam, while 887 patients also received 50 mcg fentanyl. The median dose of flumazenil was 0.2 mg. Oxygen desaturation (sO2 <92 %) occurred in 15 % during the procedure without an effect on recovery and discharge times. Patients left the department 65 min after the last midazolam administration. The majority (82.7 %) were fully alert during their journey home. At home, 2.7 % went to bed, 45.2 % took a nap, and 40 % undertook activities. Almost every patient (98.8 %) liked the shortened recovery time. Three patients had an incident (fainting, fall, and near-fall) without consequences. Based on this low incidence, a non-inferiority comparison of midazolam–flumazenil with midazolam-recovery would require a total of 32,650 patients.
Conclusions
Administration of flumazenil resulted in a safe shortening of the recovery period and offers the possibility for substantial savings in time, space, and nurse resources. A non-inferiority comparison will not be practicable.
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References
Cohen LB, Wecsler JS, Gaetano JN, et al. Endoscopic sedation in the United States: results from a nationwide survey. Am J Gastroenterol. 2006;101:967–974.
Froehlich F, Harris JK, Wietlisbach V, Burnand B, Vader JP, Gonvers JJ. Current sedation and monitoring practice for colonoscopy: an International Observational Study (EPAGE). Endoscopy. 2006;38:461–469.
McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc. 2008;67:910–923.
Bartelsman JF, Sars PR, Tytgat GN. Flumazenil used for reversal of midazolam-induced sedation in endoscopy outpatients. Gastrointest Endosc. 1990;36:S9–S12.
Wille RT, Chaffee BW, Ryan ML, Elta GH, Walter V, Barnett JL. Pharmacoeconomic evaluation of flumazenil for routine outpatient EGD. Gastrointest Endosc. 2000;51:282–287.
Dunton AW, Schwam E, Pitman V, McGrath J, Hendler J, Siegel J. Flumazenil: US clinical pharmacology studies. Eur J Anaesthesiol. 1988;2:81–95.
Pearson RC, McCloy RF, Morris P, Bardhan KD. Midazolam and flumazenil in gastroenterology. Acta Anaesthesiol Scand. 1990;92:21–24.
Rosario MT, Costa NF. Combination of midazolam and flumazenil in upper gastrointestinal endoscopy, a doubleblind randomized study. Gastrointest Endosc. 1990;36:30–33.
Saletin M, Malchow H, Muhlhofer H, Fischer M, Pilot J, Rohde H. A randomised controlled trial to evaluate the effects of flumazenil after midazolam premedication in outpatients undergoing colonoscopy. Endoscopy. 1991;23:331–333.
Kankaria A, Lewis JH, Ginsberg G, et al. Flumazenil reversal of psychomotor impairment due to midazolam or diazepam for conscious sedation for upper endoscopy. Gastrointest Endosc. 1996;44:416–421.
Ghouri AF, Ruiz MA, White PF. Effect of flumazenil on recovery after midazolam and propofol sedation. Anesthesiology. 1994;81:333–339.
American Society of Anesthesiologists (ASA). Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology. 2002;96:1004–1017.
Dutch Association for Anesthesiology, CBO—Quality Institute for Health Services. Guideline Sedation and/or Analgesia in Adults Outside the Operation Theatre. www.anesthesiologie.nl.
Riphaus A, Gstettenbauer T, Frenz MB, Wehrmann T. Quality of psychomotor recovery after propofol sedation for routine endoscopy: a randomized and controlled study. Endoscopy. 2006;38:677–683.
Dumonceau JM, Riphaus A, Aparicio JR, et al. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010;42:960–974.
Qadeer MA, Vargo JJ, Khandwala F, Lopez R, Zuccaro G. Propofol versus traditional sedative agents for gastrointestinal endoscopy: a meta-analysis. Clin Gastroenterol Hepatol. 2005;3:1049–1056.
Wehrmann T, Riphaus A. Sedation with propofol for interventional endoscopic procedures: a risk factor analysis. Scand J Gastroenterol. 2008;43:368–374.
Bauer TM, Ritz R, Haberthur C, et al. Prolonged sedation due to accumulation of conjugated metabolites of midazolam. Lancet. 1995;346:145–147.
Cohen LB, Delegge MH, Aisenberg J, et al. AGA Institute review of endoscopic sedation. Gastroenterology. 2007;133:675–701.
Riphaus A, Wehrmann T, Weber B, et al. S3 guideline: sedation for gastrointestinal endoscopy 2008. Endoscopy. 2008;41:787–815.
Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995;7:89–91.
Jensen S, Knudsen L, Kirkegaard L, Kruse A, Knudsen EB. Flumazenil used for antagonizing the central effects of midazolam and diazepam in outpatients. Acta Anaesthesiol Scand. 1989;33:26–28.
Whitwam JG. The use of midazolam and flumazenil in diagnostic and short surgical procedures. Acta Anaesthesiol Scand. 1990;92:16–20.
Whitwam JG. Resedation. Acta Anaesthesiol Scand. 1990;92:70–74.
Andrews PJ, Wright DJ, Lamont MC. Flumazenil in the outpatient. A study following midazolam as sedation for upper gastrointestinal endoscopy. Anaesthesia. 1990;45:445–448.
Girdler NM, Lyne JP, Wallace R, et al. A randomised crossover trial of postoperative cognitive and psychomotor recovery from benzodiazepine sedation: effects of reversal with flumazenil over a prolonged recovery period. Br Dent J. 2002;192:335–339.
Maeda S, Miyawaki T, Higuchi H, Shimada M. Effect of flumazenil on disturbance of equilibrium function induced by midazolam. Anaesth Prog. 2008;55:73–77.
Willey J, Vargo JJ, Connor JT, Dumot JA, Conwell DL, Zuccaro G. Quantitative assessment of psychomotor recovery after sedation and analgesia for outpatient EGD. Gastrointest Endosc. 2002;56:810–816.
Horiuchi A, Nakayama Y, Hidaka N, Ichise Y, Kajiyama M, Tanaka N. Low-dose propofol sedation for diagnostic esophagogastroduodenoscopy: results in 10,662 adults. Am J Gastroenterol. 2009;104:1650–1655.
Carter AS, Bell GD, Coady T, Lee J, Morden A. Speed of reversal of midazolam-induced respiratory depression by flumazenil—a study in patients undergoing upper GI endoscopy. Acta Anaesthesiol Scand. 1990;92:59–64.
Mora CT, Tjorjman M, DiGiorgio K. Sedative and ventilatory effects of midazolam and flumazenil. Anesthesiology. 1987;67:A534.
Mora CT, Torjman M, White PF. Sedative and ventilatory effects of midazolam infusion: effect of flumazenil reversal. Can J Anaesth. 1995;42:677–684.
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The authors are deeply indebted to the department of Anesthesiology for their help and advice.
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10620_2014_3061_MOESM1_ESM.tif
Supplemental figure. Time in minutes from the administration of midazolam to arrival in the recovery room, administration of flumazenil, discharge, arrival at home, and end of sleep for 649 patients (289 in upper and 360 in lower endoscopy) who took a nap. ***p < 0.001 for the comparison of times between upper and lower endoscopy (TIFF 488 kb)
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Mathus-Vliegen, E.M.H., de Jong, L. & Kos-Foekema, H.A. Significant and Safe Shortening of the Recovery Time After Flumazenil-Reversed Midazolam Sedation. Dig Dis Sci 59, 1717–1725 (2014). https://doi.org/10.1007/s10620-014-3061-2
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DOI: https://doi.org/10.1007/s10620-014-3061-2