Pharmacokinetics of Dexmedetomidine in Morbid Obesity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01864187|
Recruitment Status : Unknown
Verified March 2015 by bo xu, Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was: Recruiting
First Posted : May 29, 2013
Last Update Posted : March 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Drug: Dexmedetomidine||Phase 4|
For the obese are sensitive to the disease such as hypertension, ischaemic heart disease and diabetes, the changes of the state may affect the pharmacokinetics of dexmedetomidine. Besides,the clearance of dexmedetomidine is parallel with liver function and it is excreted by kidney, so differences in the obese may be expected.
About 10 obese patients and 10 matched healthy volunteers with normal weight would be chosen to receive a normal dosage of dexmedetomidine. And venous samples will be collected in different time points. Next the investigators can get the plasma concentration of dexmedetomidine by the use of HPLC-MS. And then the plasma concentration could be analyzed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of the Pharmacokinetics of Dexmedetomidine in Morbid Obesity.|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2015|
Each team will be administered for 1μg/kg of dexmedetomidine eace one.
The volunteers would receive a dosage of dexmedetomidine by 1μg/kg.
- Plasma Concentration of dexmedetomidine [ Time Frame: 0, 5, 10, 15, 20, 25, 30, 45 , 60, 90, 120, 150,180,240,360,480 hours post‐dose ]
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): NCT01864187
|Contact: bo xu||88653387 ext firstname.lastname@example.org|
|Guangzhou Military Region General Hospital, Department of Anesthesiology||Recruiting|
|Guangzhou, Guangdong, China, 510010|
|Contact: Tao Zhi Li 15625052815 ext 86 email@example.com|