Prospective, Double Blind, Placebo Control, Bariatric IV Ace

Completed · Phase 4 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT02452320

Run by

Weill Medical College of Cornell University

People needed

136

Starts

2016-02-01

Expected to finish

2017-01-01

Last updated by the study team

2018-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years old
• BMI > 30
• Undergoing Elective Sleeve Gastrectomy
• Able to consent

You may not qualify if…

• 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

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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