ObesityPhase 4NCT02187068
Dexmedetomidine Pharmacokinetics in the Obese
A Phase 4 study testing Dexmedetomidine in people with Obesity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- Apr 2012to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clinico Pontificia Universidad Catolica
Santiago, Santiago Metropolitan
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Dexmedetomidine
- Keywords
- Anaesthetics iv, Dexmedetomidine, Pharmacokinetic
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Other names:, Precedex
Dexmedetomidine administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the intraoperative period and 360 min after stopping dexmedetomidine infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis I Cortínez, MD, Principal investigator, Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187068
- Sponsor's protocol ID
- 11-142
- Status last verified
- Jul 2014
- First submitted
- 25 Jun 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Pharmacokinetics in the Obese
- ClinicalTrials.gov ID
- NCT02187068
- Acronym / sponsor ID
- 11-142
- Conditions
- Obesity
- Keywords
- Anaesthetics iv, Dexmedetomidine, Pharmacokinetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine obese 1 | Experimental | Drug: Dexmedetomidine10 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 | Experimental | Drug: Dexmedetomidine10 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 | Experimental | Drug: Dexmedetomidine10 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 | Experimental | Drug: Dexmedetomidine10 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Other names:, PrecedexDexmedetomidine administered intravenously | Drug | Dexmedetomidine non obese 2, Dexmedetomidine non-obese 1, Dexmedetomidine obese 1, Dexmedetomidine obese 2 |
Primary outcome
dexmedetomidine serum concentration
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis I Cortínez, MD principal investigator
Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Obesity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dexmedetomidine serum concentration (time frame: During the intraoperative period and 360 min after stopping dexmedetomidine infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.