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Trial record 49 of 762 for:    region | Chile

The Effect of Obesity in Dexmedetomidine Metabolic Clearance

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ClinicalTrials.gov Identifier: NCT02557867
Recruitment Status : Unknown
Verified October 2016 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Active, not recruiting
First Posted : September 23, 2015
Last Update Posted : October 12, 2016
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Tracking Information
First Submitted Date  ICMJE September 6, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date October 12, 2016
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
Dexmedetomidine plasmatic levels [ Time Frame: From start of infusion (min): 5, 10, 20, 30, 45, 60, 90, 120, 150, 180; from end of infusion (min): 5, 10, 20, 30, 60, 90, 120, 240, 360, 720 ]
Measured by high performance liquid chromatography
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02557867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2016)
  • Steatohepatitis score [ Time Frame: 3 months after liver biopsy specimen collection ]
    Using liver biopsy, a score for steatohepatitis will be applied on samples from all patients
  • Plasma disappearance rate of indocyanine [ Time Frame: 2 hours after arrival to Post-Anesthesia Care Unit ]
    Using indocyanine green and LiMON monitor (Pulsion Medical Systems) surrogate measures of liver blood flow will be registered.
  • Enzyme expression [ Time Frame: 3 months after liver biopsy specimen collection ]
    Liver samples will be analyzed for UGT2B10 and UGT1A4 expression (involved in dexmedetomidine metabolization)
  • Hemodynamics [ Time Frame: Recorded at every blood sample collection (5, 10, 20, 30, 45, 60, 90, 120, 150, 180 min) during anesthesia ]
    Heart rate and arterial pressure will be recorded during anesthesia
  • Anesthetic depth [ Time Frame: Recorded at every blood sample collection (5, 10, 20, 30, 45, 60, 90, 120, 150, 180 min) during anesthesia ]
    Using a bispectral index monitor, anesthetic depth will be monitorized through out surgery.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2015)
  • Steatohepatitis score [ Time Frame: 3 months after liver biopsy specimen collection ]
    Using liver biopsy, a score for steatohepatitis will be applied on samples from all patients
  • Plasma disappearance rate of indocyanine [ Time Frame: 2 hours after arrival to Post-Anesthesia Care Unit ]
    Using indocyanine green and LiMON monitor (Pulsion Medical Systems) surrogate measures of liver blood flow will be registered.
  • Enzyme expression [ Time Frame: 3 months after liver biopsy specimen collection ]
    Liver samples will be analyzed for UGT2B10 and UGT1A4 expression (involved in dexmedetomidine metabolization)
  • Hemodynamics [ Time Frame: Recorded at every blood sample collection (5, 10, 20, 30, 45, 60, 90, 120, 150, 180 min) during anesthesia ]
    Heart rate and arterial pressure will be recorded during anesthesia
  • Anesthetic depth [ Time Frame: Recorded at every blood sample collection (5, 10, 20, 30, 45, 60, 90, 120, 150, 180 min) during anesthesia ]
    Using a BIS monitor, anesthetic depth will be monitorized through out surgery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Obesity in Dexmedetomidine Metabolic Clearance
Official Title  ICMJE The Effect of Obesity in Dexmedetomidine Metabolic Clearance
Brief Summary The purpose of this study is to study the effect of obesity in dexmedetomidine pharmacokinetics and pharmacodynamic profile.
Detailed Description The investigators expect to find an inverse correlation between the amount of fat mass and liver blood flow or with the enzymatic metabolic capacity. Results will be based on a population pharmacokinetic modeling analysis performed in NONMEM program. The investigators will first account for the effect of different measured size scalars on volumes and clearances and then they will search for plausible covariates (liver blood flow, enzymatic capacity, degree of hepatic steatosis, etc) on dexmedetomidine metabolic clearance. A pharmacokinetic model capable of characterizing clearance changes in the obese using more plausible biological covariates will be tried to be defined.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Obesity
Intervention  ICMJE Drug: Dexmedetomidine
Dexmedetomidine 0.5 μg/kg over 10 minutes and then, 0.5 mcg/kg/h throughout surgery.
Other Name: Precedex
Study Arms  ICMJE
  • Experimental: Obese
    Body composition measurement before surgery using Dual energy X-ray absorptiometry. Dexmedetomidine infusion during surgery. Venous blood sampling for dexmedetomidine plasmatic levels during and after surgery. Liver blood flow indirect non-invasive assessment after surgery using indocyanine. Liver biopsy during surgery.
    Intervention: Drug: Dexmedetomidine
  • Experimental: Non-obese
    Body composition measurement before surgery using Dual energy X-ray absorptiometry. Dexmedetomidine infusion during surgery. Venous blood sampling for dexmedetomidine plasmatic levels during and after surgery. Liver blood flow indirect non-invasive assessment after surgery using indocyanine. Liver biopsy during surgery.
    Intervention: Drug: Dexmedetomidine
Publications *

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 21, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for obese patients:

  • American Society of Anesthesiology classification I-III patients.
  • Both genders.
  • Age between 18 - 60 years.
  • Body mass index higher than 40 Kg/m2.

Inclusion Criteria for non-obese patients:

  • American Society of Anesthesiology classification I-II patients
  • Both genders.
  • Age between 18 - 60 years
  • Body mass index lower than 30 Kg/m2.

Exclusion Criteria:

  • Known allergy to study drugs
  • Uncontrolled hypertension.
  • Heart block greater than first degree.
  • Chronic hepatic and kidney disease.
  • Patients taking any drug acting in the central nervous system within 24 hrs before surgery.
  • Patients taking drugs that induce overexpression of liver cytochrome P450-complex enzymes (Carbamazepine, Phenytoin, Phenobarbital, Rifampicin, Dexamethasone, Griseofulvin, Terbinafine, Prednisone, Hydrocortisone, Modafinil).)
  • Known addiction to illicit drugs.
  • Pregnancy.
  • Current or past oncologic disease.
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 NCT02557867
Other Study ID Numbers  ICMJE 14-253
1150197 ( Other Grant/Funding Number: FONDECYT )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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 Associate Professor Ordinary Category
PRS Account Pontificia Universidad Catolica de Chile
Verification Date October 2016

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