Phase 4
N=128
Prospective, Double Blind, Placebo Control, Bariatric IV Ace
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02452320 ↗Enrolled (actual)
128
Serious AEs
0.8%
Results posted
Apr 2018
Primary outcome: Primary: Quality of Recovery-15 Patient Survey — 107.2; 108.6; 118.3; 117.1 units on a scale — p=0.59
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- intravenous acetaminophen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Recovery-15 Patient Survey |
107.2; 108.6; 118.3; 117.1 | 0.59 |
| SECONDARY Length of Hospital Stay |
1.96; 1.87 | — |
| SECONDARY Hospital Costs |
12,977; 12,885 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02452320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.