, Volume 35, Issue 2, pp 282-290
Date: 16 Sep 2008

Dexmedetomidine versus propofol/midazolam for long-term sedation during mechanical ventilation

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Abstract

Purpose

To compare dexmedetomidine (DEX) with standard care (SC, either propofol or midazolam) for long-term sedation in terms of maintaining target sedation and length of intensive care unit (ICU) stay.

Methods

A pilot, phase III, double-blind multicenter study in randomized medical and surgical patients (n = 85) within the first 72 h of ICU stay with an expected ICU stay of ≥48 h and sedation need for ≥24 h after randomization. Patients were assigned to either DEX (≤1.4 μg kg−1 h−1; n = 41) or SC (n = 44), with daily sedation stops.

Results

Non-inferiority of DEX versus SC was not confirmed. Target Richmond agitation–sedation score (RASS) was reached a median of 64% (DEX) and 63% (SC) of the sedation time (ns). The length of ICU stay was similar in DEX and SC. Patients with RASS target 0–3 (DEX 78%, SC 80%) were at target sedation 74% (DEX) and 64% (SC) of the time (ns), whereas those with RASS target −4 or less reached the target 42% (DEX) and 62% (SC) of the time (P = .006). Post hoc analyses suggested shorter duration of mechanical ventilation for DEX (P = 0.025).

Conclusions

This pilot study suggests that in long-term sedation, DEX is comparable to SC in maintaining sedation targets of RASS 0 to −3 but not suitable for deep sedation (RASS −4 or less). DEX had no effect on length of ICU stay. Its effects on other relevant clinical outcomes, such as duration of mechanical ventilation, should be tested further.

Registered at ClinicalTrials.gov, number NCT00226785.
A complete list of investigators and study centers appears in the Appendix.
This study was sponsored by Orion Pharma, Helsinki, Finland, through research contracts negotiated directly with the participating hospitals.