Prospective, Double Blind, Placebo Control, Bariatric IV Ace
NCT02452320 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2018-04-20
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.
Conditions
Interventions
- DRUG
-
intravenous acetaminophen
administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
- DRUG
-
Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
Sponsors & Collaborators
-
Weill Medical College of Cornell University
lead OTHER
Principal Investigators
-
Peter A Goldstein, MD · Weill Medical College of Cornell University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-29
- Primary Completion
- 2017-01-31
- Completion
- 2017-01-31
Countries
- United States
Study Locations
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