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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis I CortÃnez, MD | Departamento de AnestesiologÃa, Hospital ClÃnico Pontificia Universidad Católica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Pontificia Universidad Catolica | Santiago | Santiago Metropolitan | Chile |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |