Pharmacokinetics of Dexmedetomidine in Morbid Obesity

Phase 4

• Conditions: Obesity
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT01864187
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-29
• Study Start: 2013-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	Each team will be administered for 1μg/kg of dexmedetomidine eace one.

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of dexmedetomidine	0, 5, 10, 15, 20, 25, 30, 45 , 60, 90, 120, 150,180,240,360,480 hours post-dose

Trial Locations

Locations (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology; 🇨🇳 Guangzhou, Guangdong, China