ObesityNCT02982928
Tylenol Levels in Bariatric Patients
An observational study of Obesity, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The current study is designed to measure and evaluate the pharmacokinetic profiling of acetaminophen in the young obese patient population. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Obesity
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 22 Jan 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of 30 patients presenting to the OR for robotic assisted or laparoscopic bariatric surgery.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Keywords
- Obesity, Bariatrics, Acetaminophen, robot-assisted or laparoscopic bariatric surgery, Pharmacokinetics
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra- and Post-operative Serum Concentrations
To determine whether adequate serum concentration of acetaminophen is achieved.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study start6 Mar 2017
- Primary completion22 Jan 2018
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahsan Syed, Nationwide Children's Hospital
- Investigators
- Ahsan Syed, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982928
- Sponsor's protocol ID
- IRB15-00471
- Status last verified
- Mar 2019
- First submitted
- 2 Dec 2016
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ziemann-Gimmel P, Hensel P, Koppman J, Marema R. Multimodal analgesia reduces narcotic requirements and antiemetic rescue medication in laparoscopic Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):975-80. doi: 10.1016/j.soard.2013.02.003. Epub 2013 Feb 13.
PubMed 23499469Saurabh S, Smith JK, Pedersen M, Jose P, Nau P, Samuel I. Scheduled intravenous acetaminophen reduces postoperative narcotic analgesic demand and requirement after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):424-30. doi: 10.1016/j.soard.2014.09.017. Epub 2014 Sep 30.
PubMed 25614351Abernethy DR, Divoll M, Greenblatt DJ, Ameer B. Obesity, sex, and acetaminophen disposition. Clin Pharmacol Ther. 1982 Jun;31(6):783-90. doi: 10.1038/clpt.1982.111.
PubMed 7075126Lee WH, Kramer WG, Granville GE. The effect of obesity on acetaminophen pharmacokinetics in man. J Clin Pharmacol. 1981 Jul;21(7):284-7. doi: 10.1002/j.1552-4604.1981.tb01768.x.
PubMed 7263926Birmingham PK, Tobin MJ, Henthorn TK, Fisher DM, Berkelhamer MC, Smith FA, Fanta KB, Cote CJ. Twenty-four-hour pharmacokinetics of rectal acetaminophen in children: an old drug with new recommendations. Anesthesiology. 1997 Aug;87(2):244-52. doi: 10.1097/00000542-199708000-00010.
PubMed 9286887
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetaminophen Pharmacokinetics in Bariatric Patients
- ClinicalTrials.gov ID
- NCT02982928
- Acronym / sponsor ID
- IRB15-00471
- Conditions
- Obesity
- Keywords
- Obesity, Bariatrics, Acetaminophen, robot-assisted or laparoscopic bariatric surgery, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of 30 patients presenting to the OR for robotic assisted or laparoscopic bariatric surgery.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23499469Ziemann-Gimmel P, Hensel P, Koppman J, Marema R. Multimodal analgesia reduces narcotic requirements and antiemetic rescue medication in laparoscopic Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):975-80. doi: 10.1016/j.soard.2013.02.003. Epub 2013 Feb 13.
- Background: PubMed 25614351Saurabh S, Smith JK, Pedersen M, Jose P, Nau P, Samuel I. Scheduled intravenous acetaminophen reduces postoperative narcotic analgesic demand and requirement after laparoscopic Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):424-30. doi: 10.1016/j.soard.2014.09.017. Epub 2014 Sep 30.
- Background: PubMed 7075126Abernethy DR, Divoll M, Greenblatt DJ, Ameer B. Obesity, sex, and acetaminophen disposition. Clin Pharmacol Ther. 1982 Jun;31(6):783-90. doi: 10.1038/clpt.1982.111.
- Background: PubMed 7263926Lee WH, Kramer WG, Granville GE. The effect of obesity on acetaminophen pharmacokinetics in man. J Clin Pharmacol. 1981 Jul;21(7):284-7. doi: 10.1002/j.1552-4604.1981.tb01768.x.
- Background: PubMed 9286887Birmingham PK, Tobin MJ, Henthorn TK, Fisher DM, Berkelhamer MC, Smith FA, Fanta KB, Cote CJ. Twenty-four-hour pharmacokinetics of rectal acetaminophen in children: an old drug with new recommendations. Anesthesiology. 1997 Aug;87(2):244-52. doi: 10.1097/00000542-199708000-00010.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahsan Syed, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982928, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.