Tylenol Levels in Bariatric Patients

March 20, 2019 updated by: Ahsan Syed, Nationwide Children's Hospital

Acetaminophen Pharmacokinetics in Bariatric Patients

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of 30 patients presenting to the OR for robotic assisted or laparoscopic bariatric surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra- and Post-operative Serum Concentrations
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
To determine whether adequate serum concentration of acetaminophen is achieved.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Ahsan Syed, MD, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2017

Primary Completion (Actual)

January 22, 2018

Study Completion (Actual)

January 22, 2018

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB15-00471

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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