Pharmacokinetics of Propofol in Morbidly Obese Patients | NCT01536002 | Trialant
CompletedInterventionalPhase 4Updated May 31, 2017
Pharmacokinetics of Propofol in Morbidly Obese Patients
Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients
ClinicalTrials.gov ID
NCT01536002
Lead Sponsor
Oslo University HospitalOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
69Actual
Last Update Posted
May 31, 2017Actual
Start Date
Jun 7, 2011Actual
Primary Completion Date
May 7, 2014Actual
Completion Date
May 7, 2014Actual
Official Title
Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients
Brief Summary
The objectives of this study are
To determine PK of propofol in bariatric patients
To identify the physiological variables that induce propofol PK changes in bariatric patients, when compared to a normal-weight population.
To define context-sensitive half-time profiles for propofol in bariatric patients.
Obesity, Morbid
Propofol
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
Consecutive patients admitted to the Aker University Hospital, scheduled for general or bariatric surgery,
Both genders. Female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative pregnancy test (urine beta-HCG).
Aged 18 - 60 years, both inclusive
Body mass index (BMI) ≥ 20 kg/m2
Written informed consent
Exclusion Criteria:
Patients that are considered not to tolerate a standard dose of propofol administered as a bolus.
Known hypersensitivity to propofol or its ingredients (soy, lecithin, glycerol, oil acid)
Known hypersensitivity to any of the anesthetic agents to be used