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The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.
With on-going emphasis on early extubation, as well as further recognition of morbidity and mortality associated with delirium, the specific sedatives and analgesics used in the ICU is an issue of interest. Recent studies have focused on comparing sedatives, but interpretations are often confounded by the fact that in most studies, different analgesics were used when comparing two sedative medications. The role of remifentanil as the main analgesic in the ICU is being recognized. Pharmacodynamic and pharmacokinetic profiles of remifentanil makes it an ideal analgesic in the ICU setting. The investigators therefore designed this randomized study to compare sedation with propofol and midazolam in a remifentanil-based sedation and analgesia.
The purpose of this study is to compare propofol-remifentanil sedation with midazolam-remifentanil sedation in regards to extubation and weaning time, length of stay in the ICU, as well as the incidence of delirium. Primary end-points were weaning time and extubation time, and secondary end-points were the incidence of delirium and length of stay in the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol | Active Comparator |
| |
| Midazolam | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol infusion | Drug | IV propofol 2% at a rate of 1.0 mg kg-1 h-1, increments or decrements of 0.1 mg kg-1 h-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extubation time | the time to extubation : defined as the time from discontinuation of infusion to extubation | monitored from dicontinuation of sedatives to extubation, during an expected average of 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| delirium | delirium assessed by Confusion Assessment Method for ICU (CAM-ICU) | monitored during the entire ICU stay (an expected average of 6 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 120-752 | South Korea |
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| Midazolam infusion | Drug | midazolam at a rate of 0.1 mg kg-1 h-1, increments or decrements of 0.05 mg kg-1 h-1 |
|