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      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

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          Abstract

          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

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          Most cited references18

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          Long-term sedation in intensive care unit: a randomized comparison between inhaled sevoflurane and intravenous propofol or midazolam.

          To evaluate efficacy and adverse events related to inhaled sevoflurane for long-term sedation compared with standard intravenous (i.v.) sedation with propofol or midazolam. Randomized controlled trial. Sixty intensive care unit (ICU) patients expected to require more than 24 h sedation were randomly assigned to one of three groups: group S, inhaled sevoflurane; group P, i.v. propofol; group M, i.v. midazolam. All patients also received i.v. remifentanil for goal-directed sedation (Ramsay scale and pain score) until extubation or for a maximum of 96 h. Primary end points were wake-up times and extubation delay from termination of sedative administration. Proportion of time within Ramsay score 3-4, i.v. morphine consumption at 24 h post extubation, hallucination episodes after end of sedation, adverse events, inorganic fluoride plasma levels, and ambient sevoflurane concentrations were recorded. Forty-seven patients were analyzed. Wake-up time and extubation delay were significantly (P<0.01) shorter in group S (18.6 ± 11.8 and 33.6 ± 13.1 min) than in group P (91.3 ± 35.2 and 326.11 ± 360.2 min) or M (260.2 ± 150.2 and 599.6 ± 586.6 min). Proportion of time within desired interval of sedation score was comparable between groups. Morphine consumption during the 24 h following extubation was lower in group S than in groups P and M. Four hallucination episodes were reported in group P, five in group M, and none in group S (P=0.04). No hepatic or renal adverse events were reported. Mean plasma fluoride value was 82 μmol l(-1) (range 12-220 μmol l(-1)), and mean ambient sevoflurane concentration was 0.3 ± 0.1 ppm. Long-term inhaled sevoflurane sedation seems to be a safe and effective alternative to i.v. propofol or midazolam. It decreases wake-up and extubation times, and post extubation morphine consumption, and increases awakening quality. © Copyright jointly held by Springer and ESICM 2011
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            Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device.

            To test the efficacy and patient safety of a new method for administering isoflurane for prolonged sedation in the intensive care unit. Randomized controlled trial. Multidisciplinary university intensive care unit, January 2002 to July 2003. Forty ventilator-dependent intensive care unit patients 18-80 yrs old, expected to need >12 hrs sedation. Patients were randomized to sedation with inhaled isoflurane via the Anesthetic Conserving Device or intravenous midazolam infusion. Study duration was 96 hrs or until extubation. Primary end points were wake-up times from termination of sedative administration and proportion of time within a predefined desired interval on a sedation scale (Bloomsbury Sedation Score). Practical and patient-related complications with the Anesthetic Conserving Device were noted. Hemodynamic, hepatic, and renal side effects were monitored. Wake-up times were significantly shorter in the isoflurane group than in the control group (time to extubation [mean +/- sd] 10 +/- 5 vs. 252 +/- 271 mins, time to follow verbal command 10 +/- 8 vs. 110 +/- 132 mins). Proportion of time within the desired sedation interval was comparable between groups (isoflurane 54%, midazolam 59% of sedation time). Few minor practical problems with this new method for isoflurane administration were noted. No serious complications related to either sedative drug occurred. We found no hemodynamic, hepatic, or renal adverse effects related to either sedative protocol. Isoflurane via the Anesthetic Conserving Device is a safe and efficacious method for sedation in the intensive care unit, with short wake-up times after termination of administration. The Anesthetic Conserving Device allows easily titratable administration of isoflurane without costly equipment and can be safely managed by nursing staff.
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              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 randomised trial [ISRCTN47583497]

              Introduction This randomised, open-label, multicentre study compared the safety and efficacy of an analgesia-based sedation regime using remifentanil with a conventional hypnotic-based sedation regime in critically ill patients requiring prolonged mechanical ventilation for up to 10 days. Methods One hundred and five randomised patients received either a remifentanil-based sedation regime (initial dose 6 to 9 μg kg-1 h-1 (0.1 to 0.15 μg kg-1 min-1) titrated to response before the addition of midazolam for further sedation (n = 57), or a midazolam-based sedation regime with fentanyl or morphine added for analgesia (n = 48). Patients were sedated to an optimal Sedation–Agitation Scale (SAS) score of 3 or 4 and a pain intensity (PI) score of 1 or 2. Results The remifentanil-based sedation regime significantly reduced the duration of mechanical ventilation by more than 2 days (53.5 hours, P = 0.033), and significantly reduced the time from the start of the weaning process to extubation by more than 1 day (26.6 hours, P < 0.001). There was a trend towards shortening the stay in the intensive care unit (ICU) by 1 day. The median time of optimal SAS and PI was the same in both groups. There was a significant difference in the median time to offset of pharmacodynamic effects when discontinuing study medication in patients not extubated at 10 days (remifentanil 0.250 hour, comparator 1.167 hours; P < 0.001). Of the patients treated with remifentanil, 26% did not receive any midazolam during the study. In those patients that did receive midazolam, the use of remifentanil considerably reduced the total dose of midazolam required. Between days 3 and 10 the weighted mean infusion rate of remifentanil remained constant with no evidence of accumulation or of a development of tolerance to remifentanil. There was no difference between the groups in SAS or PI score in the 24 hours after stopping the study medication. Remifentanil was well tolerated. Conclusion Analgesia-based sedation with remifentanil was well tolerated; it reduces the duration of mechanical ventilation and improves the weaning process compared with standard hypnotic-based sedation regimes in ICU patients requiring long-term ventilation for up to 10 days.
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                Author and article information

                Journal
                Trials
                Trials
                Trials
                BioMed Central
                1745-6215
                2012
                10 August 2012
                : 13
                : 135
                Affiliations
                [1 ]University Clinic for Anaesthesiology and Operative Intensive Care Medicine Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany
                [2 ]Institute of Medical Epidemiology, Biostatistics, and Informatics, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany
                [3 ]Coordination Centre for Clinical Trials, Martin-Luther-University Halle-Wittenberg, Halle/Saale, Germany
                [4 ]Clinic for Anaesthesiology, Intensive Care Therapy and Palliative Medicine, Carl-Thiem-Clinic Cottbus, Cottbus, Germany
                [5 ]Clinic for Anaesthesiology and Critical Care Medicine, University Hospital Rostock, Rostock, Germany
                Article
                1745-6215-13-135
                10.1186/1745-6215-13-135
                3502585
                22883020
                1cae6c25-62bc-444f-840c-6977498497d6
                Copyright ©2012 Soukup et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 23 January 2012
                : 26 July 2012
                Categories
                Study Protocol

                Medicine
                intravenous sedation,sevoflurane,intensive care,inhalative sedation
                Medicine
                intravenous sedation, sevoflurane, intensive care, inhalative sedation

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