NCT02187068

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 obesity

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

8 months

First QC Date

June 25, 2014

Last Update Submit

July 7, 2014

Conditions

Obesity

Keywords

Anaesthetics ivDexmedetomidinePharmacokinetic

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Dexmedetomidine obese 1

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Dexmedetomidine obese 2

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Dexmedetomidine non-obese 1

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Dexmedetomidine non obese 2

EXPERIMENTAL

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.

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Dexmedetomidine administered intravenously

Also known as: Other names:, Precedex
Dexmedetomidine non obese 2Dexmedetomidine non-obese 1Dexmedetomidine obese 1Dexmedetomidine obese 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Pontificia Universidad Catolica

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Obesity

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Luis I Cortínez, MD

    Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2014

First Posted

July 10, 2014

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

May 1, 2014

Last Updated

July 10, 2014

Record last verified: 2014-07

Locations

CL(1)