Dexmedetomidine Pharmacokinetics in the Obese

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02187068

Enrollment

Registered

2014-07-10

Start date

2012-04-30

Completion date

2014-05-31

Last updated

2014-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Anaesthetics iv, Dexmedetomidine, Pharmacokinetic

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.

Interventions

DRUGDexmedetomidine

Dexmedetomidine administered intravenously

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026