Pharmacokinetics of Dexmedetomidine in Morbid Obesity
A Study of the Pharmacokinetics of Dexmedetomidine in Morbid Obesity.
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 obesity
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2013
CompletedFirst Posted
Study publicly available on registry
May 29, 2013
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMarch 12, 2015
March 1, 2015
2.1 years
May 24, 2013
March 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma Concentration of dexmedetomidine
0, 5, 10, 15, 20, 25, 30, 45 , 60, 90, 120, 150,180,240,360,480 hours post-dose
Study Arms (1)
Dexmedetomidine
EXPERIMENTALEach team will be administered for 1μg/kg of dexmedetomidine eace one.
Interventions
The volunteers would receive a dosage of dexmedetomidine by 1μg/kg.
Eligibility Criteria
You may qualify if:
- Weight:28≦BMI≦45 and 18.5≦BMI≦24
- Written informed consent from the patient or the relatives of the participating patient.
You may not qualify if:
- A previous history of intolerance to the study drug or related compounds and additives.
- Existing significant haematological, endocrine, metabolic or gastrointestinal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010, China
Related Publications (2)
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.
PMID: 22030215BACKGROUNDXu 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.
PMID: 28828532DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate chief physician
Study Record Dates
First Submitted
May 24, 2013
First Posted
May 29, 2013
Study Start
June 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
March 12, 2015
Record last verified: 2015-03