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

NCT ID: NCT02056678

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Cholecystitis Cholelithiasis Obstructive Sleep Apnea

Keywords

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cholecystitis cholelithiasis obstructive sleep apnea acetaminophen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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IV acetaminophen, OSA, laparoscopic cholecystectomy

IV acetaminophen 1000mg to be administered to obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy

Group Type ACTIVE_COMPARATOR

acetaminophen, IV preparation

Intervention Type DRUG

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acetaminophen, IV preparation

Intervention Type DRUG

Other Intervention Names

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Ofirmev

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erik Boatman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

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University Health System

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22096275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18931212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22401881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19144748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24350194 (View on PubMed)

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.

Reference Type RESULT
PMID: 22783709 (View on PubMed)

Other Identifiers

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HSC20140011H

Identifier Type: -

Identifier Source: org_study_id