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

Obstructive Sleep Apnea Clinical Trial

Official title:

Use of IV Acetaminophen Intraoperatively in Obese Patients at Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02056678
• Other study ID #: HSC20140011H
• Status: Withdrawn
• Phase: Phase 4
• First received: February 5, 2014
• Last updated: November 2, 2016
• Start date: February 2014
• Est. completion date: June 2014

Study information

• Verified date: November 2016
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Cholecystitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• acetaminophen, IV preparation

Locations

Country	Name	City	State
United States	University Health System	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PACU stay (1-2 hours)	No
Secondary	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.	PACU stay (1-2 hours)	Yes
Secondary	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.	PACU stay (1-2 hours)	No