Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA
Primary Purpose
Cholecystitis, Cholelithiasis, Obstructive Sleep Apnea
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
acetaminophen, IV preparation
Sponsored by
About this trial
This is an interventional treatment trial for Cholecystitis focused on measuring cholecystitis, cholelithiasis, obstructive sleep apnea, acetaminophen
Eligibility 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
Sites / Locations
- University Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
IV acetaminophen, OSA, laparoscopic cholecystectomy
OSA, laparoscopic cholecystectomy, narcotics
Arm Description
IV acetaminophen 1000mg to be administered to obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy
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
Outcomes
Primary Outcome Measures
reduction in pain scores in PACU
The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in pain scores in the PACU
Secondary Outcome Measures
reduced narcotic use in PACU
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
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.
Full Information
NCT ID
NCT02056678
First Posted
February 5, 2014
Last Updated
November 2, 2016
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT02056678
Brief Title
Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA
Official Title
Use of IV Acetaminophen Intraoperatively in Obese Patients at Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator left institution
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Cholelithiasis, Obstructive Sleep Apnea
Keywords
cholecystitis, cholelithiasis, obstructive sleep apnea, acetaminophen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV acetaminophen, OSA, laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
IV acetaminophen 1000mg to be administered to obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy
Arm Title
OSA, laparoscopic cholecystectomy, narcotics
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
acetaminophen, IV preparation
Other Intervention Name(s)
Ofirmev
Primary Outcome Measure Information:
Title
reduction in pain scores in PACU
Description
The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in pain scores in the PACU
Time Frame
PACU stay (1-2 hours)
Secondary Outcome Measure Information:
Title
reduced narcotic use in PACU
Description
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.
Time Frame
PACU stay (1-2 hours)
Title
amount of time for recovery in PACU based on Aldrete score
Description
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.
Time Frame
PACU stay (1-2 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Boatman, MD
Organizational Affiliation
University of Texas Health Science Center- San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22096275
Citation
Ankichetty S, Wong J, Chung F. A systematic review of the effects of sedatives and anesthetics in patients with obstructive sleep apnea. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):447-58. doi: 10.4103/0970-9185.86574.
Results Reference
background
PubMed Identifier
18931212
Citation
Chung SA, Yuan H, Chung F. A systemic review of obstructive sleep apnea and its implications for anesthesiologists. Anesth Analg. 2008 Nov;107(5):1543-63. doi: 10.1213/ane.0b013e318187c83a.
Results Reference
background
PubMed Identifier
22401881
Citation
Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.
Results Reference
background
PubMed Identifier
19144748
Citation
Lavie L. Obstructive sleep apnoea and acetaminophen safety - is the liver at risk? Exp Physiol. 2009 Feb;94(2):199-200. doi: 10.1113/expphysiol.2008.045906. No abstract available.
Results Reference
background
PubMed Identifier
24350194
Citation
O'Neal JB. The utility of intravenous acetaminophen in the perioperative period. Front Public Health. 2013 Aug 6;1:25. doi: 10.3389/fpubh.2013.00025.
Results Reference
background
PubMed Identifier
22783709
Citation
Abdulla S, Eckhardt R, Netter U, Abdulla W. A randomized, double-blind, controlled trial on non-opioid analgesics and opioid consumption for postoperative pain relief after laparoscopic cholecystectomy. Acta Anaesthesiol Belg. 2012;63(1):43-50.
Results Reference
result
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Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA
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