Cholecystitis, Cholelithiasis, Obstructive Sleep Apnea
Conditions
Keywords
cholecystitis, cholelithiasis, obstructive sleep apnea, acetaminophen
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.
Interventions
DRUGacetaminophen, IV preparation
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction in pain scores in PACU | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reduced narcotic use in PACU | 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 | 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. |
Countries
United States
Outcome results
None listed