Remifentanil versus fentanyl for analgesia based sedation to provide patient comfort in the intensive care unit: a randomized, double-blind controlled trial [ISRCTN43755713] (original) (raw)
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Crit Care, 2006
Introduction Remifentanil is an opioid with a unique pharmacokinetic profile. Its organ-independent elimination and short context-sensitive half time of 3 to 4 minutes lead to a highly predictable offset of action. We tested the hypothesis that with an analgesia-based sedation regimen with remifentanil and propofol, patients after cardiac surgery reach predefined criteria for discharge from the intensive care unit (ICU) sooner, resulting in shorter duration of time spent in the ICU, compared to a conventional regimen consisting of midazolam and fentanyl. In addition, the two regimens were compared regarding their costs. Methods In this prospective, open-label, randomised, singlecentre study, a total of 80 patients (18 to 75 years old), who had undergone cardiac surgery, were postoperatively assigned to one of two treatment regimens for sedation in the ICU for 12 to 72 hours. Patients in the remifentanil/propofol group received remifentanil (6-max. 60 µg kg-1 h-1 ; dose exceeds recommended labelling). Propofol (0.5 to 4.0 mg kg-1 h-1) was supplemented only in the case of insufficient sedation at maximal remifentanil dose. Patients in the midazolam/fentanyl group received midazolam (0.02 to 0.2 mg kg-1 h-1) and fentanyl (1.0 to 7.0 µg kg-1 h-1). For treatment of pain after extubation, both groups received morphine and/or non-opioid analgesics. Results The time intervals (mean values ± standard deviation) from arrival at the ICU until extubation (20.7 ± 5.2 hours versus 24.2 h ± 7.0 hours) and from arrival until eligible discharge from the ICU (46.1 ± 22.0 hours versus 62.4 ± 27.2 hours) were significantly (p < 0.05) shorter in the remifentanil/propofol group. Overall costs of the ICU stay per patient were equal (approximately €1,700 on average). Conclusion Compared with midazolam/fentanyl, a remifentanilbased regimen for analgesia and sedation supplemented with propofol significantly reduced the time on mechanical ventilation and allowed earlier discharge from the ICU, at equal overall costs.
Critical care (London, England), 2006
Remifentanil is an opioid with a unique pharmacokinetic profile. Its organ-independent elimination and short context-sensitive half time of 3 to 4 minutes lead to a highly predictable offset of action. We tested the hypothesis that with an analgesia-based sedation regimen with remifentanil and propofol, patients after cardiac surgery reach predefined criteria for discharge from the intensive care unit (ICU) sooner, resulting in shorter duration of time spent in the ICU, compared to a conventional regimen consisting of midazolam and fentanyl. In addition, the two regimens were compared regarding their costs. In this prospective, open-label, randomised, single-centre study, a total of 80 patients (18 to 75 years old), who had undergone cardiac surgery, were postoperatively assigned to one of two treatment regimens for sedation in the ICU for 12 to 72 hours. Patients in the remifentanil/propofol group received remifentanil (6- max. 60 microg kg(-1) h(-1); dose exceeds recommended label...
Intensive Care Medicine, 2011
A prospective, randomized, double-blind, multicenter study comparing remifentanil with fentanyl in mechanically ventilated patients Abstract Purpose: To compare the quality of analgesia provided by a remifentanil-based analgesia regime with that provided by a fentanylbased regime in critically ill patients. Methods: This was a registered, prospective, two-center, randomized, triple-blind study involving adult medical and surgical patients requiring mechanical ventilation (MV) for more than 24 h. Patients were randomized to either remifentanil infusion or a fentanyl infusion for a maximum of 30 days. Sedation was provided using propofol (and/or midazolam if required). Results: Primary outcome was the proportion of patients in each group maintaining a target analgesia score at all time points. Secondary outcomes included duration of MV, discharge times, and morbidity. At planned interim analysis (n = 60), 50% of remifentanil patients (n = 28) and 63% of fentanyl patients (n = 32) had maintained target analgesia scores at all time points (p = 0.44). There were no significant differences between the groups with respect to mean duration of ventilation (135 vs. 165 h, p = 0.80), duration of hospital stay, morbidity, or weaning. Interim analysis strongly suggested futility and the trial was stopped. Conclusions: The use of remifentanil-based analgesia in critically ill patients was not superior regarding the achievement and maintenance of sufficient analgesia compared with fentanyl-based analgesia.
Anesthesiology Clinics, 2011
Patients who are critically ill and on mechanical ventilation frequently require sedation and analgesic therapy to optimize patient comfort, facilitate patient-ventilator synchrony, and optimize oxygenation. 1 Despite the 2002 Society of Critical Care Medicine (SCCM) pain and sedation guideline recommendations that sedation and analgesic therapy be titrated to maintain patients in a pain-free and slightly sleepy state, recent data suggests that these endpoints are frequently not obtained. 2-5 For example, one large observational study of sedation practices in 44 French ICUs found that 57% of patients on day 2 and 41% on day 6 were found to be deeply sedated (ie, sedation agitation score 2). 3 The etiology of oversedation in the ICU is complex and has many drug and nondrug causes. 1 Clinicians in the ICU are often slow to incorporate into practice sedation strategies that have been shown to reduce the duration of mechanical ventilation, such as protocolization and daily interruption of sedative administration. 6-8 Even more important is the failure by clinicians to consider the numerous pharmacokinetic, pharmacodynamic, and pharmacogenetic factors that influence analgesic and sedative response, recovery, and safety in patients who are critically ill.
The American Journal of Geriatric Pharmacotherapy, 2007
Background: It is unclear how best to measure sedative/analgesic drug exposure in the clinical care of critically ill patients. Large doses and prolonged use of sedatives and analgesics in the intensive care unit (ICU) may lead to oversedation and adverse effects, including delirium and long-term cognitive impairment. These issues are of particular concern in elderly patients (aged _>65 years), who account for at least half of all ICU admissions and nearly two thirds of ICU days.