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Completed

NCT Number: NCT02187068

Dexmedetomidine Pharmacokinetics in the Obese

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinico Pontificia Universidad Catolica

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Dexmedetomidine administered intravenously

Other names: Other names:, Precedex

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
Jul 10, 2014
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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