Dexmedetomidine Pharmacokinetics in the Obese

Obesity Clinical Trial

Official title:

Dexmedetomidine Pharmacokinetics in the Obese

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187068
• Other study ID #: 11-142
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2014
• Last updated: July 7, 2014
• Start date: April 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Dexmedetomidine
Dexmedetomidine administered intravenously

Locations

Country	Name	City	State
Chile	Hospital Clinico Pontificia Universidad Catolica	Santiago	Región metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dexmedetomidine serum concentration	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	During the intraoperative period and 360 min after stopping dexmedetomidine infusion	No