Prospective, Double Blind, Placebo Control, Bariatric IV Ace

NCT02452320 | Completed Phase 4 Results

• 1 other identifier: 1503016056
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

bariatric; Post-operative nausea and vomiting; laparoscopic Sleeve gastrectomy; intravenous acetaminophen

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-15 Patient Survey

  Survey asking 15 questions with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Possible scores range from 0-150, and scores with a higher value indicate a better outcome. Each subject was administered a baselineQoR-15 survey prior to surgery, and then one on postoperative days (POD) 1 and 2. If a subject was discharged prior to POD2, they were not given a QoR-15 survey that day.

  Patients will be followed for the duration of hospital stay, expected average of 3 days.

Secondary Outcomes (2)

• Length of Hospital Stay

  Participants will be followed for the duration of hospital stay, expected average of 3 days.

• Hospital Costs

  Costs incurred during hospital stay, expected average of 3 days.

Study Arms (2)

Control

PLACEBO COMPARATOR

Subjects randomized into the control group will not receive study medication, they will receive a placebo administered at the same schedule as the active drug in the other arm.

Drug: Placebo

Randomized

ACTIVE COMPARATOR

Subjects randomized into the active treatment group will receive intravenous acetaminophen

Drug: intravenous acetaminophen

Interventions

intravenous acetaminophen DRUG

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

Also known as: Ofirmev

Randomized

Placebo 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

Also known as: Normal Saline

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Obesity; Vomiting

Interventions

Acetaminophen; Saline Solution

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Limitations of this study: Did not follow subjects after discharge and therefore do not have any re-admission data (if applicable). Relatively small sample size.

Results Point of Contact

• Title: Farrell Cooke, Senior Research Assistant
• Organization: Weill Cornell Medicine

fac2010@med.cornell.edu

212-746-2774

Study Officials

• Peter A Goldstein, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 22, 2015
• Study Start: February 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 20, 2018
• Results First Posted: April 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)