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Pharmacokinetics of Dexmedetomidine in Morbid Obesity

Primary Purpose

Obesity

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Guangzhou General Hospital of Guangzhou Military Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Pharmacokinetics, Dexmedetomidine, Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Guangzhou Military Region General Hospital, Department of AnesthesiologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dexmedetomidine

Arm Description

Each team will be administered for 1μg/kg of dexmedetomidine eace one.

Outcomes

Primary Outcome Measures

Plasma Concentration of dexmedetomidine

Secondary Outcome Measures

Full Information

First Posted
May 24, 2013
Last Updated
March 11, 2015
Sponsor
Guangzhou General Hospital of Guangzhou Military Command
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1. Study Identification

Unique Protocol Identification Number
NCT01864187
Brief Title
Pharmacokinetics of Dexmedetomidine in Morbid Obesity
Official Title
A Study of the Pharmacokinetics of Dexmedetomidine in Morbid Obesity.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou General Hospital of Guangzhou Military Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Pharmacokinetics, Dexmedetomidine, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Each team will be administered for 1μg/kg of dexmedetomidine eace one.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
The volunteers would receive a dosage of dexmedetomidine by 1μg/kg.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Weight:28≦BMI≦45 and 18.5≦BMI≦24 Written informed consent from the patient or the relatives of the participating patient. Exclusion Criteria: A previous history of intolerance to the study drug or related compounds and additives. Existing significant haematological, endocrine, metabolic or gastrointestinal disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
bo xu
Phone
88653387
Ext
020
Email
xubo333@hotmail.com
Facility Information:
Facility Name
Guangzhou Military Region General Hospital, Department of Anesthesiology
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Zhi Li
Phone
15625052815
Ext
86
Email
lytow@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22030215
Citation
Iirola T, Aantaa R, Laitio R, Kentala E, Lahtinen M, Wighton A, Garratt C, Ahtola-Satila T, Olkkola KT. Pharmacokinetics of prolonged infusion of high-dose dexmedetomidine in critically ill patients. Crit Care. 2011;15(5):R257. doi: 10.1186/cc10518. Epub 2011 Oct 26.
Results Reference
background
PubMed Identifier
28828532
Citation
Xu B, Zhou D, Ren L, Shulman S, Zhang X, Xiong M. Pharmacokinetic and pharmacodynamics of intravenous dexmedetomidine in morbidly obese patients undergoing laparoscopic surgery. J Anesth. 2017 Dec;31(6):813-820. doi: 10.1007/s00540-017-2399-y. Epub 2017 Aug 21.
Results Reference
derived

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Pharmacokinetics of Dexmedetomidine in Morbid Obesity

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