A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects
This trial is active, not recruiting.
|Start date||January 2011|
|End date||July 2017|
|Trial size||40 participants|
|Trial identifier||NCT01591148, 16509-JI, Stanford-16509|
This study will determine how morbid obesity affects the distribution and metabolism of the drug propofol. The investigators hypothesize that propofol will be distributed and metabolized differently in morbidly obese subjects as compared to normal weight subjects.
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||parallel assignment|
plasma drug concentration of propofol
time frame: measured during the perioperative period
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: - adult age (ages 18-70) - body mass index greater than 40 or between 20-25 - American Society of Anesthesiologists Class I, II, or III - undergoing elective surgical procedure requiring general anesthesia Exclusion Criteria: - evidence of cardiovascular or pulmonary disease - kidney or liver dysfunction - drug allergy to propofol - history of difficult airway - on prescribed or over the counter anxiolytics, antipsychotics, or sleeping aids - unable to speak or understand English
|Official title||A High Resolution Pharmacokinetic/Pharmacodynamic Model of Propofol in Morbidly Obese Subjects|
|Principal investigator||Jerry Ingrande, M.D., M.S.|
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