A Phase 4 interventional study of Propofol in Obesity, sponsored by Universidad del Desarrollo. Completed at 1 site in Chile. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-15.
Sponsored by Universidad del Desarrollo · Phase 4, Interventional, and Supportive care
The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of a single bolus dose of propofol in obese patients and to extract a time to peak effect (t-peak) from the estimated model parameters.
Target controlled infusion (TCI) is a technique to administer intravenous drugs that allows rapid achievement and maintenance of predetermined drug concentrations, either in plasma (Cp) or at the site of effect (Ce).
To characterize the time profile of propofol effect an additional parameter, the equilibration half time between plasma and effect site (T1/2keo) needs to be incorporated in the pharmacokinetic (PK) model.
Universidad del Desarrollo is the lead sponsor of 23 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
14 obese patients(IMC\>35 kg m-2) scheduled for laparoscopic bariatric surgery
Drug: Propofol
Propofol was administered by plasma TCI and a bolus dose was given by setting the initial plasma target between 12-16 μg/ml according to the anesthesiologist criteria. The protocol target range was selected based on previous experience using this model in the obese. After the patients reached this target, propofol infusion was stopped until the patients woke up (BIS\>75). No other drugs were given during this period. Facemask ventilation was assisted only if necessary to maintain SpO2 \> 90%. BIS data and propofol infusion data were automatically recorded every five seconds using the AnestFusor© program. Arterial blood samples of 4 ml for propofol assays were collected at 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS \> 75. After the patient woke up the study was considered finished and propofol infusion was restarted according to the anesthesiologist plan.
Profile of Pharmacokinetic and Pharmacodynamic of an induction bolus dose of propofol in obese patients.
Pharmacokinetic parameters (V1, V2, V3, CL, Q) Pharmacodynamic parameters (E0, Emax, C50, Gamma, t1/2Ke0, T peak )
Time frame: 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Universidad del Desarrollo