Early Sedation with Dexmedetomidine in Critically Ill Patients.

Shehabi, Yahya; Howe, Belinda D; Bellomo, Rinaldo; Arabi, Yaseen M; Bailey, Michael; Bass, Frances E; Bin Kadiman, Suhaini; McArthur, Colin J; Murray, Lynnette; Reade, Michael C; Seppelt, Ian M; Takala, Jukka; Wise, Matt P; Webb, Steven A (2019). Early Sedation with Dexmedetomidine in Critically Ill Patients. The New England journal of medicine, 380(26), pp. 2506-2517. Massachusetts Medical Society 10.1056/NEJMoa1904710

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BACKGROUND Dexmedetomidine produces sedation while maintaining a degree of arousability and may reduce the duration of mechanical ventilation and delirium among patients in the intensive care unit (ICU). The use of dexmedetomidine as the sole or primary sedative agent in patients undergoing mechanical ventilation has not been extensively studied. METHODS In an open-label, randomized trial, we enrolled critically ill adults who had been undergoing ventilation for less than 12 hours in the ICU and were expected to continue to receive ventilatory support for longer than the next calendar day to receive dexmedetomidine as the sole or primary sedative or to receive usual care (propofol, midazolam, or other sedatives). The target range of sedation-scores on the Richmond Agitation and Sedation Scale (which is scored from -5 [unresponsive] to +4 [combative]) was -2 to +1 (lightly sedated to restless). The primary outcome was the rate of death from any cause at 90 days. RESULTS We enrolled 4000 patients at a median interval of 4.6 hours between eligibility and randomization. In a modified intention-to-treat analysis involving 3904 patients, the primary outcome event occurred in 566 of 1948 (29.1%) in the dexmedetomidine group and in 569 of 1956 (29.1%) in the usual-care group (adjusted risk difference, 0.0 percentage points; 95% confidence interval, -2.9 to 2.8). An ancillary finding was that to achieve the prescribed level of sedation, patients in the dexmedetomidine group received supplemental propofol (64% of patients), midazolam (3%), or both (7%) during the first 2 days after randomization; in the usual-care group, these drugs were administered as primary sedatives in 60%, 12%, and 20% of the patients, respectively. Bradycardia and hypotension were more common in the dexmedetomidine group. CONCLUSIONS Among patients undergoing mechanical ventilation in the ICU, those who received early dexmedetomidine for sedation had a rate of death at 90 days similar to that in the usual-care group and required supplemental sedatives to achieve the prescribed level of sedation. More adverse events were reported in the dexmedetomidine group than in the usual-care group. (Funded by the National Health and Medical Research Council of Australia and others; SPICE III ClinicalTrials.gov number, NCT01728558.).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Intensive Care, Emergency Medicine and Anaesthesiology (DINA) > Clinic of Intensive Care

UniBE Contributor:

Takala, Jukka

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1533-4406

Publisher:

Massachusetts Medical Society

Language:

English

Submitter:

Mirella Aeberhard

Date Deposited:

05 Aug 2019 11:08

Last Modified:

23 Oct 2019 12:27

Publisher DOI:

10.1056/NEJMoa1904710

PubMed ID:

31112380

Additional Information:

Trial Personnel Universitätsklinik für Intensivmedizin gem. SPICE III Supplementary Appendix Management committee: Jukka Takala Writing committee: Jukka Takala Affiliations of the writing committee: Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (JT); University of Bern, Bern, Switzerland (JT) Site investigators: Inselspital Bern University Hospital, Bern, CH, M. Akaltan, S. Berger, D. Blaser, L. Fazlija, ML. Jong, M. Lensch, R. Ludwig, T. Merz, K. Nettelbeck, M. Roth, M. Schafer, J. Takala, A. Wehr, D. Zacharias

BORIS DOI:

10.7892/boris.131405

URI:

https://boris.unibe.ch/id/eprint/131405

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