Overview

This trial is active, not recruiting.

Condition obesity
Treatment dexmedetomidine
Phase phase 4
Sponsor Pontificia Universidad Catolica de Chile
Start date August 2015
End date October 2016
Trial size 40 participants
Trial identifier NCT02557867, 1150197, 14-253

Summary

The purpose of this study is to study the effect of obesity in dexmedetomidine pharmacokinetics and pharmacodynamic profile.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Body composition measurement before surgery using Dual energy X-ray absorptiometry. Dexmedetomidine infusion during surgery. Venous blood sampling for dexmedetomidine plasmatic levels during and after surgery. Liver blood flow indirect non-invasive assessment after surgery using indocyanine. Liver biopsy during surgery.
dexmedetomidine Precedex
Dexmedetomidine 0.5 μg/kg over 10 minutes and then, 0.5 mcg/kg/h throughout surgery.
(Experimental)
Body composition measurement before surgery using Dual energy X-ray absorptiometry. Dexmedetomidine infusion during surgery. Venous blood sampling for dexmedetomidine plasmatic levels during and after surgery. Liver blood flow indirect non-invasive assessment after surgery using indocyanine. Liver biopsy during surgery.
dexmedetomidine Precedex
Dexmedetomidine 0.5 μg/kg over 10 minutes and then, 0.5 mcg/kg/h throughout surgery.

Primary Outcomes

Measure
Dexmedetomidine plasmatic levels
time frame: From start of infusion (min): 5, 10, 20, 30, 45, 60, 90, 120, 150, 180; from end of infusion (min): 5, 10, 20, 30, 60, 90, 120, 240, 360, 720

Secondary Outcomes

Measure
Steatohepatitis score
time frame: 3 months after liver biopsy specimen collection
Plasma disappearance rate of indocyanine
time frame: 2 hours after arrival to Post-Anesthesia Care Unit
Enzyme expression
time frame: 3 months after liver biopsy specimen collection
Hemodynamics
time frame: Recorded at every blood sample collection (5, 10, 20, 30, 45, 60, 90, 120, 150, 180 min) during anesthesia
Anesthetic depth
time frame: Recorded at every blood sample collection (5, 10, 20, 30, 45, 60, 90, 120, 150, 180 min) during anesthesia

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria for obese patients: - American Society of Anesthesiology classification I-III patients. - Both genders. - Age between 18 - 60 years. - Body mass index higher than 40 Kg/m2. Inclusion Criteria for non-obese patients: - American Society of Anesthesiology classification I-II patients - Both genders. - Age between 18 - 60 years - Body mass index lower than 30 Kg/m2. Exclusion Criteria: - Known allergy to study drugs - Uncontrolled hypertension. - Heart block greater than first degree. - Chronic hepatic and kidney disease. - Patients taking any drug acting in the central nervous system within 24 hrs before surgery. - Patients taking drugs that induce overexpression of liver cytochrome P450-complex enzymes (Carbamazepine, Phenytoin, Phenobarbital, Rifampicin, Dexamethasone, Griseofulvin, Terbinafine, Prednisone, Hydrocortisone, Modafinil).) - Known addiction to illicit drugs. - Pregnancy. - Current or past oncologic disease.

Additional Information

Official title The Effect of Obesity in Dexmedetomidine Metabolic Clearance
Principal investigator Luis I Cortínez, MD
Description The investigators expect to find an inverse correlation between the amount of fat mass and liver blood flow or with the enzymatic metabolic capacity. Results will be based on a population pharmacokinetic modeling analysis performed in NONMEM program. The investigators will first account for the effect of different measured size scalars on volumes and clearances and then they will search for plausible covariates (liver blood flow, enzymatic capacity, degree of hepatic steatosis, etc) on dexmedetomidine metabolic clearance. A pharmacokinetic model capable of characterizing clearance changes in the obese using more plausible biological covariates will be tried to be defined.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pontificia Universidad Catolica de Chile.