Obesity
Conditions
Keywords
Obesity, Bariatrics, Acetaminophen, robot-assisted or laparoscopic bariatric surgery, Pharmacokinetics
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.
Interventions
None listed
Sponsors
Nationwide Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bariatric Surgery Obese pediatric and young adult patients undergoing robotic or laparoscopic bariatric surgery (vertical sleeve gastrectomy). | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Bariatric Surgery |
|---|---|
| Age, Categorical <=18 years | 7 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 17 years STANDARD_DEVIATION 2 |
| BMI (kg/m2) | 46 Kg/m2 STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Intra- and Post-operative Serum Concentrations
To determine whether adequate serum concentration of acetaminophen is achieved.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery | Intra- and Post-operative Serum Concentrations | 15-20 minutes | 17 µg.mL-1 | Standard Deviation 4 |
| Bariatric Surgery | Intra- and Post-operative Serum Concentrations | 30-40 minutes | 14 µg.mL-1 | Standard Deviation 3 |
| Bariatric Surgery | Intra- and Post-operative Serum Concentrations | 50-70 minutes | 9 µg.mL-1 | Standard Deviation 6 |
| Bariatric Surgery | Intra- and Post-operative Serum Concentrations | 80-100 minutes | 5 µg.mL-1 | Standard Deviation 6 |
| Bariatric Surgery | Intra- and Post-operative Serum Concentrations | 2 hours | 0 µg.mL-1 | Standard Deviation 0 |
| Bariatric Surgery | Intra- and Post-operative Serum Concentrations | 4 hours | 0 µg.mL-1 | Standard Deviation 0 |
| Bariatric Surgery | Intra- and Post-operative Serum Concentrations | 8 hours | 0 µg.mL-1 | Standard Deviation 0 |
| Bariatric Surgery | Intra- and Post-operative Serum Concentrations | 12 hours | 0 µg.mL-1 | Standard Deviation 0 |