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
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
reduction in pain scores in PACU
Secondary Outcome
reduced narcotic use in PACU
Condition
Cholecystitis
Intervention
acetaminophen, IV preparation
Study Arms / Comparison Groups
IV acetaminophen, OSA, laparoscopic cholecystectomy
Description: IV acetaminophen 1000mg to be administered to obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
February 2014
Completion Date
June 2014
Primary Completion Date
June 2014
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Erik Boatman, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02056678
Organization ID
HSC20140011H
Responsible Party
Sponsor
Study Sponsor
The University of Texas Health Science Center at San Antonio
Study Sponsor
Erik Boatman, MD, Principal Investigator, University of Texas Health Science Center- San Antonio
Verification Date
November 2016