A Phase 2 interventional study of Remimazolam Besylate and Propofol in Critically Ill and Deep Sedation, sponsored by Wuhan Union Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-26.
Sponsored by Wuhan Union Hospital, China · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of remimazolam besylate compared to propofol for sedation in critically ill patients with deep sedation.
This is a single-center, prospective, randomized, controlled study using remimazolam besylate and propofol for sedation in critically ill patients with deep sedation. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Wuhan Union Hospital, China is the lead sponsor of 230 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.3 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.
Drug: Remimazolam Besylate
Patients in the propofol group received propofol at an initial infusion rate of 3.0 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.
Drug: Propofol
sedation drugs
Propofol
The percentage of time in the target sedation range without rescue sedation
The percentage of time in the target sedation range without rescue sedation
Time frame: From the beginning of using study sedatives until being discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first
Adverse events
Adverse events
Time frame: From the beginning of using study sedatives until being discharged from our ICU, the sedation target was changed, 48 hours after enrollment, or dead, whichever came first
7-day ventitlator free time
7-day ventitlator free time
Time frame: From start of study to 7 days
Extubation at day 7
Extubation at day 7
Time frame: From start of study to 7 days
Length of ICU stay
Length of ICU stay
Time frame: From start of study to 28 days
28-day mortality
28-day mortality
Time frame: From start of study to 28 days
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Wuhan Union Hospital, China