Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA

November 2, 2016 updated by: The University of Texas Health Science Center at San Antonio

Use of IV Acetaminophen Intraoperatively in Obese Patients at Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Cholecystectomy

The objective of this study is to determine if IV acetaminophen administered intraoperatively can decrease the dose of narcotics required for adequate pain control and shorten recovery time in the PACU specifically in obese patients at risk for obstructive sleep apnea.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obese adult patients at risk for having OSA will be randomized into two groups: those receiving intraoperative IV acetaminophen and those not receiving the drug. The patients will be blinded to the administration of acetaminophen. For the group randomized to receive the study drug, anesthesia providers will be instructed to administer 1000mg of IV acetaminophen intraoperatively immediately after induction. They may utilize narcotics and other pain medication perioperatively at their discretion according to their perceived patients' needs. Post-operatively in the recovery unit, all patients will be monitored according to current standards with appropriate oxygen supplementation as needed, and they may receive narcotics or other adjuncts as ordered by the anesthesia provider. Recovery nurses will record vital signs, Aldrete score, pain score, and drugs administered per standard protocol. The recovery nurses will be blinded to the study group, and no patients regardless of control vs. study group will be allowed to receive acetaminophen in the PACU or for six hours from surgery end time due to FDA approved dosing of IV acetaminophen no more frequently than every six hours. The patients' recovery data will then be de-identified and reviewed, and each of the groups' recovery time, narcotic use, pain score, and any complications will be examined and compared.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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
    • Texas
      • San Antonio, Texas, United States, 78229
        • University Health System

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obesity (BMI greater than or equal to 30)
  • Symptoms of obstructive sleep apnea as determined by an OSA questionnaire patients will complete preoperatively
  • Prior diagnosis of obstructive sleep apnea
  • Undergoing laparoscopic cholecystectomy
  • 18 years old or greater

Exclusion Criteria:

  • Negative OSA questionnaire or recent negative workup
  • Open cholecystectomy or conversion to open procedure intraoperatively
  • Allergy to acetaminophen
  • Severe hepatic dysfunction
  • Pediatric patients
  • Patients unable to consent for themselves

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: IV acetaminophen, OSA, laparoscopic cholecystectomy
IV acetaminophen 1000mg to be administered to obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy
Drug: acetaminophen, IV preparation
Other Names:
  • Ofirmev
No Intervention: OSA, laparoscopic cholecystectomy, narcotics
No IV acetaminophen in obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy; patients will receive other modalities for pain control primarily including IV narcotics

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
reduction in pain scores in PACU
Time Frame: PACU stay (1-2 hours)
The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in pain scores in the PACU
PACU stay (1-2 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
reduced narcotic use in PACU
Time Frame: PACU stay (1-2 hours)
The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in narcotic use in the PACU and therefore have less adverse events related to increased narcotic use such as respiratory depression or failure requiring prolonged supplemental oxygen or respiratory support, increased nausea and vomiting, longer PACU stay, and allergic reactions.
PACU stay (1-2 hours)
amount of time for recovery in PACU based on Aldrete score
Time Frame: PACU stay (1-2 hours)
The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in recovery time, i.e., reduction in time to the patient's baseline Aldrete score.
PACU stay (1-2 hours)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center at San Antonio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erik Boatman, MD, University of Texas Health Science Center- San Antonio

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC20140011H

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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