Pharmacokinetics of Dexmedetomidine in Morbid Obesity

A Study of the Pharmacokinetics of Dexmedetomidine in Morbid Obesity.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01864187

Enrollment

Registered

2013-05-29

Start date

2013-06-30

Completion date

2015-07-31

Last updated

2015-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Pharmacokinetics, Dexmedetomidine, Obesity

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.

Interventions

DRUGDexmedetomidine

The volunteers would receive a dosage of dexmedetomidine by 1μg/kg.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary Contactbo xu

xubo333@hotmail.com88653387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026