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Withdrawn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

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
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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
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- 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
- 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.
- 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 |
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

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
United States, Texas | |
University Health System | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Erik Boatman, MD | University of Texas Health Science Center- San Antonio |
Publications of Results:
Other Publications:
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 |
cholecystitis cholelithiasis obstructive sleep apnea acetaminophen |
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 |