Table 1 Salient features of key sedation trials conducted in the last 15 years
From: Intensive care sedation: the past, present and the future
Authors (Year) | Design (Number) | Time to randomly assign | Main inclusion | Patients/intervention versus control | Time on treatment | Primary outcome | Main results |
|---|---|---|---|---|---|---|---|
Mehta et al. [37] (2012) | Multicenter RCT open-label (423) | 1 to 4 days | Ventilated >48 hours | Medical 80%+, DSI + PS versus PS. All patients received MDZ and received SBT. | Until extubated median 7 days | Time to extubation | No difference in outcomes |
Jakob et al. [27] (2012) | Multicenter two RCTs Double-blind | 48 hours of sedation | Ventilated >48 hours | Medical Surgical and Trauma Dex versus MDZ and | Median 42 (23-72) hours for Dex | Time at target sedation RASS −3 to 0 | No difference in primary outcome. Shorter time to |
| Â | (998, 2 studies) | Â | Â | Dex versus Propofol. All patients DSI, SBT | Â | Â | extubation |
Strøm et al. [14] (2010) | Single-center Unblinded RCT (140 but 113 analyzed) | 24 hours after intubation | Ventilated >24 hours | General ICU patients Morphine versus propofol (first 48 hours) then MDZ. DSI conducted in all patients | Not given. Study staff intervened 2-5 days | Ventilator-free days at 28 days after intubation | More ventilator-free days, shorter ICU and hospital stays |
Treggiari et al. [33] (2009) | Single-center Open-label RCT (129) | Up to 3 days | Ventilated >12 hours | Mainly post-surgical (80%+) Light sedation versus deep sedation using Ramsay scale | Mean days Light 2.9 versus deep 5.5 | Post-traumatic stress at 28 days | Trend to lower post-traumatic stress |
Skrobic et al. [31] (2010) | Single-center Pre and post (572 and 561) | 24 hours after ICU admission | Admitted >24 hours | Protocolized analgesia and sedation with non-pharmacologic intervention (music) | Through ICU stay | Sedative and analgesic needs | Shorter ICU and hospital stays, less sub-syndromal delirium |
Riker et al. [26] (2009) | Multicenter RCT double-blind (375 at 2:1) | Up to 96 hours | Ventilated >24 hours | Medical 85%+ Dex versus MDZ, rescue MDZ Sedation titration to RASS | Median days Dex 3.5 (2-5.2) versus MDZ 4.1 (2.8-6.1) | Time in target RASS −2 to +1 | No difference in RASS range. Shorter ventilation time and less |
| Â | Â | Â | Â | Fentanyl opioid of choice | Â | Â | delirium |
Girard et al. [30] (2008) | Multicenter RCT Unblinded (335) | 2.2 to 4 days | Ventilated >12 hours | General ICU SAT and SBT versus usual sedation care and SBT Research personnel involved | Time to pass SBT 3.8 (1-14), 3.9 (1-11) | Ventilator-free days | More ventilator-free days and lower 12-month risk of death |
De Wit et al. [35] (2008) | Single-center RCT unblinded (74) | Not reported | Ventilated in medical ICU | Medical respiratory ICU DSI versus sedation protocol | 6.7 (4-10) days | Ventilation time | Terminated early; higher mortality longer vent time |
Bucknall et al. [32] (2008) | Single-center RCT unblinded (312) | Not reported | Ventilated in ICU | Medical/surgical/trauma PS versus usual sedation practice | Ventilation hours 79 protocol 59 control | Ventilation time | No difference in outcomes |
Pandharipande et al. [40] (2007) | 2-center RCT double-blind (106) | 48 hours after mechanical ventilation | Ventilated >24 hours | Medical 70%+/surgical Dex versus lorazepam Rescue propofol and fentanyl | 5 (2-6) Dex versus 4 (2-6) lorazepam | Delirium-free days, coma-free days | Higher coma-free days but no effect on delirium |
Carson et al. [25] (2006) | 2-center RCT Open-label (132) over 56 months | 1.5 days on average after ventilation | Ventilated >48 hours + lorazepam >10 mg/hour | Medical ICU patients Lorazepam boluses versus propofol infusion with DSI | Not reported. Ventilation times 5.8 versus 8.4 days lorazepam | Ventilation time | Shorter ventilation time and ICU stay, more ventilation-free days |
Kress et al. [34] (2000) | Single-center RCT unblinded (128) | Ventilated patients | Ventilated >48 hours and sedated | Medical ICU DSI started 48 hours after enrollment versus usual care. Research personnel involved | Not reported. Ventilation times 4.9 versus 7.3 days | Ventilation and ICU time | Reduced ventilation time and ICU stay |
Brook et al. [30] (1999) | Single-center RCT unblinded (321) | Ventilated and in ICU >24 hours | Ventilated >24 hours | Medical ICU patients sedated with lorazepam. Nurse-implemented PS versus usual care | 3.5 (4) days in protocol versus 5.6 (6.4) days controls | Ventilation time | Shorter ventilation time and ICU stay |