Tylenol Levels in Bariatric Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-06

Study Completion Date

2018-01-22

Brief Summary

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The current study is designed to measure and evaluate the pharmacokinetic profiling of acetaminophen in the young obese patient population.

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No