Not provided
Not provided
Not provided
Not provided
Not provided
Investigator left institution
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV acetaminophen, OSA, laparoscopic cholecystectomy | Active Comparator | IV acetaminophen 1000mg to be administered to obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy |
|
| OSA, laparoscopic cholecystectomy, narcotics | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetaminophen, IV preparation | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erik Boatman, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health System | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22096275 | Background | 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. | |
| 18931212 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D002769 | Cholelithiasis |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D012891 | Sleep Apnea Syndromes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PACU stay (1-2 hours) |
| 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) |
| 22401881 | Background | 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. |
| 19144748 | Background | 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. |
| 24350194 | Background | 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. |
| 22783709 | Result | 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. |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |