Prospective, Double Blind, Placebo Control, Bariatric IV Ace

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the administration of acetaminophen given intravenously (through an IV) beginning during surgery and then for 3 additional doses during the first 24 hours post-operatively will reduce the length of time subjects undergoing elective sleeve gastrectomy spend in the hospital following this operation. Additional questions that may be answered include whether administration of the study medication leads to improvement in pain control, a reduction in post-operative nausea and vomiting, and an overall improvement in quality of recovery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• At least 18 years old

• BMI > 30

• Undergoing Elective Sleeve Gastrectomy

• Able to consent

Exclusion Criteria:

• Allergy/ Hypersensitive to acetaminophen or formulation incipients

• Allergy/Hypersensitive to aprepitant, ondasteron (serotonin type 3 receptor antagonists), dexamethasone

• Allergy to Propofol or formulation incipients (egg albumin, soy lecithin)

• Diagnosis or positive family history of malignant hyperthermia

• Abnormal LFTs (AST and ALT) >2x local upper limits of normal

• Renal impairment (creatinine clearance (CrCl) ≤ 30mL/min adjusted for obesity))

• Pregnancy

• Alcohol consumption > 3 drinks/day

• Requires awake intubation

• Unable to provide consent