A Phase 4 interventional study of Propofol in Obesity, sponsored by Pontificia Universidad Catolica de Chile. Completed at 1 site in Chile. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-11.
Sponsored by Pontificia Universidad Catolica de Chile · Phase 4, Interventional, and Supportive care
The purpose of this study is to validate an integrated pharmacokinetic-pharmacodynamic model to administer propofol in obese patients.
Our hypothesis is that pharmacokinetic and pharmacodynamic changes occur with increasing weight and that mathematical models to administer drugs in obese patients can be developed to accurately predict dose schemes in this population.
Propofol is the most frequently used IV anesthetic today. Propofol TCI is commonly used for induction and maintenance of general anaesthesia in obese and non obese patients. However, current propofol PK models, used in TCI devices, were derived from studies that did not include obese patients. A controversial issue for propofol dose adjustment in this population has been the selection of an adequate size descriptor to scale PK parameters, as drug administration based on total body weight can result in overdose, and conversely, administration based on ideal body weight can result in a sub-therapeutic dose. In a previous study from our group, we developed a PK model capable of characterizing the influence of obesity on propofol disposition. The purpose of this study is to validate this model to administer propofol in obese patients.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 20 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
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Exclusion Criteria:
20 obese patients(IMC\>35 kg m-2) scheduled for laparoscopic bariatric surgery.
Drug: Propofol
General anesthesia will be induced administering propofol by effect site TCI system using our previously derived model, the target plasma concentration initially will be set at 4 mcg/ml. After loss of consciousness, rocuronium 0.6mg/kg, and remifentanil 0.2mcg/kg/min will be given to facilitate tracheal intubation. After intubation propofol target will be decreased to 3 for 10 minutes and then adapted to the needs of each patient to maintain stable BIS values between 40 and 50. At the end of surgery propofol infusion will be stopped, and patients will be transferred to the recovery unit extubated. Samples of 2.5 ml of arterial blood will be taken at 2, 5 and 10 min after every new target is set. Thereafter samples will be taken at 2, 5, 10, 15, 30, 60, 120 min after stopping drug infusion. Blood samples will be immediately centrifuged and then stored until analysis.
Validated pharmacokinetic-pharmacodynamic model of Propofol in Obese patients
Time frame: During the intraoperative period and until 120 min after stopping propofol infusion
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Propofol
Pontificia Universidad Catolica de Chile →