Efficiency and safety of inhalative sedation with sevoflurane in comparison to an intravenous sedation concept with propofol in intensive care patients: study protocol for a randomized controlled trial

Trials

Patrick Kellner⁵  Nana-Maria Wagner¹  Jörg Steighardt³  Andreas Wienke⁴  Antje Selle⁵  Jens Soukup² 

[1] Clinic for Anaesthesiology and Critical Care Medicine, University Hospital Rostock, Rostock, Germany;Clinic for Anaesthesiology, Intensive Care Therapy and Palliative Medicine, Carl-Thiem-Clinic Cottbus, Cottbus, Germany;Coordination Centre for Clinical Trials, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany;Institute of Medical Epidemiology, Biostatistics, and Informatics, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany;University Clinic for Anaesthesiology and Operative Intensive Care Medicine Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany

关键词: Sevoflurane;    Intensive care;    Intravenous sedation;    Inhalative sedation;   

Others  :  1095415
DOI  :  10.1186/1745-6215-13-135

 received in 2012-01-23, accepted in 2012-07-26,  发布年份 2012

【 摘 要 】

Background

State of the art sedation concepts on intensive care units (ICU) favor propofol for a time period of up to 72 h and midazolam for long-term sedation. However, intravenous sedation is associated with complications such as development of tolerance, insufficient sedation quality, gastrointestinal paralysis, and withdrawal symptoms including cognitive deficits. Therefore, we aimed to investigate whether sevoflurane as a volatile anesthetic technically implemented by the anesthetic-conserving device (ACD) may provide advantages regarding ‘weaning time’, efficiency, and patient’s safety when compared to standard intravenous sedation employing propofol.

Method/Design

This currently ongoing trial is designed as a two-armed, monocentric, randomized prospective phase II study including intubated intensive care patients with an expected necessity for sedation exceeding 48 h. Patients are randomly assigned to either receive intravenous sedation with propofol or sevoflurane employing the ACD. Primary endpoint is the comparison of the ‘weaning time’ defined as the time required from discontinuation of the sedating agent until sufficient spontaneous breathing occurs. Moreover, sedation depth evaluated by Richmond Agitation Sedation Scale and parameters of patient’s safety (that is, vital signs, laboratory monitoring of organ function) as well as the duration of mechanical ventilation and overall stay on the ICU are analyzed and compared. An intention-to-treat analysis will be carried out with all patients for whom it will be possible to define a wake-up time. In addition, a per-protocol analysis is envisaged. Completion of patient recruitment is expected by the end of 2012.

Discussion

This clinical study is designed to evaluate the impact of sevoflurane during long-term sedation of critically ill patients on ‘weaning time’, efficiency, and patient’s safety compared to the standard intravenous sedation concept employing propofol.

Trial registration

EudraCT2007-006087-30; ISCRTN90609144

【 授权许可】

   
2012 Soukup et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Martin J, Heymann A, Bäsell K, Baron R, Biniek R, Bürkle H, Dall P, Dictus C, Eggers V, Eichler I, Engelmann L, Garten L, Hartl W, Haase U, Huth R, Kessler P, Kleinschmidt S, Koppert W, Kretz FJ, Laubenthal H, Marggraf G, Meiser A, Neugebauer E, Neuhaus U, Putensen C, Quintel M, Reske A, Roth B, Scholz J, Schröder S, et al.: Evidence and consensus-based German guidelines for the management of analgesia, sedation and delirium in intensive care--short version. Ger Med Sci 2010, 8:Doc02.
• [2]Badeva B, Iskrenova I, Panchev P, Gerov I, Nemtsova D, Radichkova V, Petrov P, Gerzilova L, Aluan K: Prolonged propofol (Diprivan) infusion for sedation in the critically ill. Khirurgiia 1996, 49:28-30.
• [3]Darrouj J, Karma L, Arora R: Cardiovascular manifestations of sedatives and analgesics in the critical care unit. Am J Ther 2009, 16:339-353.
• [4]Kelly DF: Propofol-infusion syndrome. J Neurosurg 2001, 95:925-926.
• [5]Ostermann ME, Keenan SP, Seiferling RA, Sibbald WJ: Sedation in the intensive care unit: a systematic trial. JAMA 2000, Suppl 11:1451-1459.
• [6]Korth M, Opitz A: Methoden der Analgosedierung in der Intensivmedizin. In Erste klinische Erfahrungen in der Langzeitsedierung mit Isofluran. Edited by Opitz A. Braunschweig: Bethel-Verlag; 1989:139-146.
• [7]Yates DW, Hughes JA: Isoflurane and long-term sedation. Anaesthesia 1993, 48:267-268.
• [8]Röhm KD, Mengistu A, Boldt J, Mayer J, Beck G, Piper SN: Renal integrity in sevoflurane sedation in the intensive care unit with the anesthetic-conserving device: a comparison with intravenous propofol sedation. Anesth Analg 2009, Suppl 6:1848-1854.
• [9]Sackey PV, Martling CR, Granath F, Radell PJ: Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med 2004, 32:2241-2246.
• [10]Breen D, Karabinis A, Malbrain M, Morais R, Albrecht S, Jarnvig IL, Parkinson P, Kirkham AJ: Decreased duration of mechanical ventilation when comparing analgesia-based sedation using remifentanil with standard hypnotic-based sedation for up to 10 days in intensive care unit patients: a randomized trial [ISRCTN47583497]. Crit Care 2005, Suppl 3:R200-R210.
• [11]Soukup J, Schärff K, Kubosch K, Pohl C, Bomplitz M, Kompardt J: State of the art: sedation concepts with volatile anesthetics in critically Ill patients. J Crit Care 2009, Suppl 4:535-544.
• [12]Mesnil M, Capdevila X, Bringuier S, Trine PO, Falquet Y, Charbit J, Roustan JP, Chanques G, Jaber S: Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam. Intensive Care Med 2011, Suppl 6:933-941.
• [13]Stuttmann R, Pillukat T, Müller-Gorges M, Knüttgen D, Doehn M: Methoden der Analgosedierung auf der Intensivstation. In Sedierung mit Isofluran unter pulmonalen und hämodynamischen Aspekten. Edited by Opitz A. Braunschweig: Bethel-Verlag; 1989:139-146.
• [14]Tanigami H, Yahagi N, Kumon K, Watanabe Y, Haruna M, Matsui J, Hayashi H: Long-term sedation with isoflurane in postoperative intensive care in cardiac surgery. Artif Organs 1997, Suppl 1:21-23.
• [15]Meiser A, Laubenthal H: Inhalational anaesthetics in the ICU: theory and practice of inhalational sedation in the ICU, economics, risk-benefit. Best Pract Res Clin Anaesthesiol 2005, Suppl 3:523-538.
• [16]Meiser A, Bellgardt M, Vogelsang H, Sirtl C, Weber T: Functioning of the anaesthetic conserving device: aspects to consider for use in inhalational sedation. Anaesthesist 2010, Suppl 11:1029-1040.
• [17]Perhag L, Reinstrup P, Thomasson R, Werner O: The Reflector: a new method for saving anaesthetic vapours. Br J Anaesth 2000, Suppl 3:482-486.
• [18]Thomasson R, Luttropp H, Werner O: A reflection filter for isoflurane and other anaesthetic vapours. Eur J Anaesthesiol 1989, 6:89-94.
• [19]Muellejans B, Matthey T, Scholpp J, Schill M: Sedation in the intensive care unit with remifentanil/propofol versus midazolam/fentanyl: a randomized, open-label, pharmacoeconomic trial. Crit Care 2006, Suppl 3:R91.
• [20]European Medicines A: ICH Harmonised Tripartite Guideline E6: Note for Guidance on Good Clinical Practice (PMP/ICH/135/95). London: European Medicines Agency; 2002.
• [21]Bundesdatenschutzgesetz (BDSG) vom 20. Dezember 1990 (BGBl. I S. 2954): neugefasst durch Bekanntmachung vom 14. Januar 2003 (BGBl. I S. 66), zuletzt geändert durch Gesetz vom 29.07.2009 (BGBl. I, S. 2254), durch Artikel 5 des Gesetzes vom 29.07. 2009. BGBl. I, S. 2355 [2384] und durch Gesetz vom 14.08.2009 (Federal Law Gazette I, S. 2814
• [22]Medicinal Products Act: in the version published on 12 December 2005 (Federal Law Gazette [BGBl.]) Part I p. 3394, last amended by Article 1 of the Ordinance of 28 September 2009. Federal Law Gazette I p. 3172
• [23]Kehl F, Smul TM, Lange M, Redel A, Roewer N: Organprotektion durch volatile Anästhetika. Anästhesiologie und Intensivmedizin 2004, 11:491-507.
• [24]Röhm KD, Wolf MW, Schöllhorn T, Schellhaass A, Boldt J, Piper SN: Short-term sevoflurane sedation using the Anaesthetic Conserving Device after cardiothoracic surgery. Intensive Care Med 2008, Suppl 9:1683-1689.
• [25]Meiser A, Sirtl C, Bellgardt M, Lohmann S, Garthoff A, Kaiser J, Hügler P, Laubenthal HJ: Desflurane compared with propofol for postoperative sedation in the intensive care unit. Br J Anaesth 2003, Suppl 3:273-280.
• [26]Migliari M, Bellani G, Rona R, Isgrò S, Vergnano B, Mauri T, Patroniti N, Pesenti A, Foti G: Short-term evaluation of sedation with sevoflurane administered by the anesthetic conserving device in critically ill patients. Intensive Care Med 2009, Suppl 7:1240-1246.