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Trial record 54 of 762 for:    region | Chile

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

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Dexmedetomidine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Dexmedetomidine Pharmacokinetics in the Obese
Study Start Date : April 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Dexmedetomidine
Dexmedetomidine administered intravenously
Other Names:
  • Other names:
  • Precedex

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.
Drug: Dexmedetomidine
Dexmedetomidine administered intravenously
Other Names:
  • Other names:
  • Precedex

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.
Drug: Dexmedetomidine
Dexmedetomidine administered intravenously
Other Names:
  • Other names:
  • Precedex

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.
Drug: Dexmedetomidine
Dexmedetomidine administered intravenously
Other Names:
  • Other names:
  • Precedex




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187068


Locations
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Chile
Hospital Clinico Pontificia Universidad Catolica
Santiago, Región metropolitana, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Luis I Cortínez, MD Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02187068     History of Changes
Other Study ID Numbers: 11-142
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014

Keywords provided by Pontificia Universidad Catolica de Chile:
Anaesthetics iv
Dexmedetomidine
Pharmacokinetic

Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action