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Dexmedetomidine Pharmacokinetics in the Obese

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ClinicalTrials.gov Identifier: NCT02187068
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Tracking Information
First Submitted Date  ICMJE June 25, 2014
First Posted Date  ICMJE July 10, 2014
Last Update Posted Date July 10, 2014
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2014)
dexmedetomidine serum concentration [ Time Frame: During the intraoperative period and 360 min after stopping dexmedetomidine infusion ]
A two compartment distribution model with first order elimination was used to describe dexmedetomidine serum concentration. Population parameter estimates were obtained using non-linear mixed effects models
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine Pharmacokinetics in the Obese
Official Title  ICMJE Dexmedetomidine Pharmacokinetics in the Obese
Brief Summary The aim of this study is to characterize, using two different modeling approaches, one based on purely statistic concept and one using a more mechanistic analysis, the influence of body weight and composition on the pharmacokinetic of dexmedetomidine.
Detailed Description Twenty obese patients and 20 non-obese patients scheduled for elective laparoscopic surgery will give dexmedetomidine 0.5 μg.kg-1 over 10 minutes and then randomized to either dexmedetomidine 0.25 mcg.kg-1.h-1 or dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples will be taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion. Population pharmacokinetic modeling will be performed using nonlinear mixed-effects model.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Obesity
Intervention  ICMJE Drug: Dexmedetomidine
Dexmedetomidine administered intravenously
Other Names:
  • Other names:
  • Precedex
Study Arms  ICMJE
  • Experimental: Dexmedetomidine obese 1
    10 obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.25 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.
    Intervention: Drug: Dexmedetomidine
  • Experimental: Dexmedetomidine obese 2
    10 obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.
    Intervention: Drug: Dexmedetomidine
  • Experimental: Dexmedetomidine non-obese 1
    10 non-obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.25 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.
    Intervention: Drug: Dexmedetomidine
  • Experimental: Dexmedetomidine non obese 2
    10 non-obese patients scheduled for elective laparoscopic surgery were given dexmedetomidine dexmedetomidine 0.5 μg.kg-1 iv over 10 minutes and then dexmedetomidine 0.5 mcg.kg-1.h-1 for approximate 2 h (range 58-320 min). Blood samples were taken at 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 min after beginning dexmedetomidine administration, and at 0, 2, 5, 10, 20, 30, 60, 90, 120, 240 and 360 min after stopping infusion.
    Intervention: Drug: Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2014)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American Society Anesthesiologist classification I-III patients
  • between 18 and 60 years of age
  • scheduled for elective laparoscopic surgery
  • obese patients with a BMI >35 kg m-2 (20 patients)
  • non-obese patients (BMI 18.5-25 kg m-2)(20 patients)

Exclusion Criteria:

  • known allergy to study drugs
  • uncontrolled hypertension
  • heart block greater than first degree
  • those who had taken any drug acting in the central nervous system 24 h before surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02187068
Other Study ID Numbers  ICMJE 11-142
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pontificia Universidad Catolica de Chile
Study Sponsor  ICMJE Pontificia Universidad Catolica de Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Luis I Cortínez, MD Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
PRS Account Pontificia Universidad Catolica de Chile
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP