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

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ClinicalTrials.gov Identifier: NCT02056678
Recruitment Status : Withdrawn (Investigator left institution)
First Posted : February 6, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE February 5, 2014
First Posted Date  ICMJE February 6, 2014
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02056678 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA
Official Title  ICMJE Use of IV Acetaminophen Intraoperatively in Obese Patients at Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Cholecystectomy
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Cholecystitis
  • Cholelithiasis
  • Obstructive Sleep Apnea
Intervention  ICMJE Drug: acetaminophen, IV preparation
Other Name: Ofirmev
Study Arms  ICMJE
  • 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
    Intervention: Drug: acetaminophen, IV preparation
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 2, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2014)
100
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02056678
Other Study ID Numbers  ICMJE HSC20140011H
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erik Boatman, MD University of Texas Health Science Center- San Antonio
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP