The Effect of Obesity in Dexmedetomidine Metabolic Clearance

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT02557867
• Date of registration: 06/09/2015
• Prospective Registration: No
• Primary sponsor: Pontificia Universidad Catolica de Chile
• Public title: The Effect of Obesity in Dexmedetomidine Metabolic Clearance
• Scientific title: The Effect of Obesity in Dexmedetomidine Metabolic Clearance
• Date of first enrolment: August 2015
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02557867
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
• Phase: Phase 4

Countries of recruitment

Chile

Contacts

• Name: Luis I Cortínez, MD
• Affiliation: Associate Professor Ordinary Category

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

Drug: Dexmedetomidine

Primary Outcome(s)

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 Outcome(s)

Anesthetic depth [Time Frame: Recorded at every blood sample collection (5, 10, 20, 30, 45, 60, 90, 120, 150, 180 min) during anesthesia]

Hemodynamics [Time Frame: Recorded at every blood sample collection (5, 10, 20, 30, 45, 60, 90, 120, 150, 180 min) during anesthesia]

Enzyme expression [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]

Steatohepatitis score [Time Frame: 3 months after liver biopsy specimen collection]

Secondary ID(s)

1150197

14-253

Source(s) of Monetary Support

Please refer to primary and secondary sponsors