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

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 4

Conditions: Cholecystitis; Cholelithiasis; Obstructive Sleep Apnea

Treatments: Drug: acetaminophen, IV preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT02056678

HSC20140011H

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

IV acetaminophen, OSA, laparoscopic cholecystectomy

Active Comparator group

Description:

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

Treatment:

Drug: acetaminophen, IV preparation

OSA, laparoscopic cholecystectomy, narcotics

No Intervention group

Description:

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