Dexmedetomidine Pharmacokinetics in the Obese
- Registration Number
- NCT02187068
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dexmedetomidine obese 1 Dexmedetomidine 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. Dexmedetomidine obese 2 Dexmedetomidine 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. Dexmedetomidine non-obese 1 Dexmedetomidine 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. Dexmedetomidine non obese 2 Dexmedetomidine 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.
- Primary Outcome Measures
Name Time Method dexmedetomidine serum concentration 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Clinico Pontificia Universidad Catolica
🇨🇱Santiago, Región metropolitana, Chile