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Pharmacokinetics of Dexmedetomidine in Morbid Obesity

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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
Sponsor:
Information provided by (Responsible Party):
bo xu, Guangzhou General Hospital of Guangzhou Military Command

Brief Summary:
Dexmedetomidine hydrochloride ,a relatively new drug in Chinais ,is a highly selective, potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects. The morbid obesity in Chinese population is rapidly increasing. But the pharmacokinetics of the drug in these people is still unknown.This research was designed to study the pharmacokinetics of dexmedetomidine in Chinese morbidly obese population.

Condition or disease Intervention/treatment Phase
Obesity Drug: Dexmedetomidine Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexmedetomidine
Each team will be administered for 1μg/kg of dexmedetomidine eace one.
Drug: Dexmedetomidine
The volunteers would receive a dosage of dexmedetomidine by 1μg/kg.




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Weight:28≦BMI≦45 and 18.5≦BMI≦24
  2. Written informed consent from the patient or the relatives of the participating patient.

Exclusion Criteria:

  1. A previous history of intolerance to the study drug or related compounds and additives.
  2. Existing significant haematological, endocrine, metabolic or gastrointestinal disease.

Information from the National Library of Medicine

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


Contacts
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Contact: bo xu 88653387 ext 020 xubo333@hotmail.com

Locations
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China, Guangdong
Guangzhou Military Region General Hospital, Department of Anesthesiology Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Tao Zhi Li    15625052815 ext 86    lytow@qq.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01864187     History of Changes
Other Study ID Numbers: Morbid Obesity
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: March 2015
Keywords provided by bo xu, Guangzhou General Hospital of Guangzhou Military Command:
Pharmacokinetics
Dexmedetomidine
Obesity
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action