Comparing the Effect of Dexmedetomidine With Midazolam on Sedation, Oxidative Stress, and Microcirculation in Intensive Care Unit
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|ClinicalTrials.gov Identifier: NCT00886275|
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : November 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Sedation Oxidative Stress||Drug: Dexmedetomidine Drug: Midazolam Drug: Dexmedetomidine, Midazolam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparing the Effect of Dexmedetomidine With Midazolam on Sedation, Oxidative Stress, and Microcirculation in Intensive Care Unit|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||April 2011|
The loading dose of dexmedetomidine is 0.5 mcg/kg over 10 minutes as needed. Then, continuous infusion of 0.2-0.7 mcg/kg/h dexmedetomidine is used to maintain RASS between 0 to -3.
|Active Comparator: Midazolam||
The loading dose of midazolam is 0.05 mg/kg over 10 minutes as needed. Then, continuous infusion of 20-300 mcg/kg/h midazolam is used to maintain RASS between 0 to -3.
Experimental: Dexmedetomidine, Midazolam
Drug: Dexmedetomidine, Midazolam
The loading doses are dexmedetomidine 0.25 mcg/kg and 0.025 mg/kg of midazolam over 10 minutes. Then, continuous infusion of 0.1-0.7 mcg/kg/h dexmedetomidine and 10-300 mcg/kg/h midazolam is used to maintain RASS between 0 to -3.
- Time to extubation [ Time Frame: hour ]
- ICU Stay Weaning parameter [ Time Frame: Hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886275
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Yu-Chang Yeh, M.D||National Taiwan University Hospital|