Tylenol Levels in Bariatric Patients
- Conditions
- Obesity
- Registration Number
- NCT02982928
- Lead Sponsor
- Nationwide Children's Hospital
- Brief Summary
The current study is designed to measure and evaluate the pharmacokinetic profiling of acetaminophen in the young obese patient population.
- Detailed Description
This will be a descriptive study carried out by study staff from the anesthesiology department. The patient population will include obese patients scheduled for robot-assisted or laparoscopic bariatric surgery. There will be no change in our usual anesthetic care for these patients. Volume of distribution and elimination half-life of acetaminophen in serum samples are the primary measurements of the study. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11
- Patients older than 12, but younger than 21 years of age undergoing robotic assisted or laparoscopic bariatric surgery
- American Society of Anesthesiologists Physical Status Classification System (ASA) I, II or III
- Parent/guardian willing and able to give consent
- Patient willing to give assent, or consent
- Patients that are otherwise healthy at the discretion of the study staff
- Patients with BMI >95th percentile
- Patients with severe right heart failure or severe asthma
- Patients with deficient hepatic function that can affect drug metabolism
- Systemic steroid use within the last 3 months
- Patients who have taken acetaminophen containing medications within 24 hours of surgery date
- Patients younger than 12, but older than 21 years of age undergoing robotic assisted or laparoscopic bariatric surgery
- Patients having other procedures in addition to robotic assisted or laparoscopic bariatric surgery
- American Society of Anesthesiologists Physical Status Classification System (ASA) IV and above
- Females testing positive for pregnancy
- Parent/guardian not willing and able to give assent, or consent
- Patient not willing to give assent, or consent
- Patients with BMI < 95th percentile
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intra- and Post-operative Serum Concentrations 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; 8 Hours; and 12-Hours Post-IV acetaminophen administration To determine whether adequate serum concentration of acetaminophen is achieved.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States