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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Recruitment Status : Withdrawn (Investigator left institution)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

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.

Condition or disease Intervention/treatment Phase
Cholecystitis Cholelithiasis Obstructive Sleep Apnea Drug: acetaminophen, IV preparation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of IV Acetaminophen Intraoperatively in Obese Patients at Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Cholecystectomy
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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 Name: 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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056678


Locations
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United States, Texas
University Health System
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Erik Boatman, MD University of Texas Health Science Center- San Antonio

Publications of Results:
Other Publications:
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02056678     History of Changes
Other Study ID Numbers: HSC20140011H
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Keywords provided by The University of Texas Health Science Center at San Antonio:
cholecystitis
cholelithiasis
obstructive sleep apnea
acetaminophen
Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics