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Trial record 1 of 1 for:    NCT02452320
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Prospective, Double Blind, Placebo Control, Bariatric IV Ace (Bariatricace)

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ClinicalTrials.gov Identifier: NCT02452320
Recruitment Status : Completed
First Posted : May 22, 2015
Results First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Obesity Drug: intravenous acetaminophen Drug: Placebo Phase 4

Detailed Description:

Morbid obesity is defined as a body mass index (BMI: weight [kg] / height [m]2) ≥ 40 or ≥ 35 if associated with comorbidities, and it is widely prevalent, nationally and globally. Overweight or obese individuals have increased morbidity and mortality. Among the many available treatment options, surgical management of obesity has been shown to be the most reliably effective in achieving sustained weight loss and improvements in glycemic, lipidemic, and blood pressure control, and improves five and ten year survival in contrast to matched controls who did not have surgery. Various surgical approaches have been used to provide long-term control of morbid obesity and its associated comorbidities, including laparoscopic sleeve gastrectomy.

During a sleeve gastrectomy the greater curvature of the stomach is separated from the lesser curvature and antrum, thereby eliminating ~85% of the total stomach, including the grehlin-producing portion of the stomach. A common complication of the procedure is postoperative nausea and vomiting (PONV), occurring in nearly 80% of patients undergoing the procedure. Risk factors for PONV include: female sex, history of PONV or motion sickness, nonsmoking, younger age, general vs. regional anesthesia, use of volatile anesthetics and nitrous oxide, administration of postoperative opioids, duration of anesthesia, and type of surgery (including cholecystectomy, laparoscopic, and gynecological). At the individual level, PONV adversely impacts both patient satisfaction and quality of life scores. At the systems level, PONV is associated with increased length of stay (LOS) in the post-anesthesia care unit and hospital, and can result in increased costs.

Both pharmacological and surgical approaches have been studied in an effort to reduce the incidence of PONV in sleeve gastrectomy patients. Omentopexy was unsuccessful, and pharmacologic prophylaxis with two [dexamethasone + odansetron; dexamethasone + granisetron; aprepitant + odansetron; or three (dexamethasone + odansetron + haloperidol; antiemetic agents was more effective than a single agent (odansetron or granisetron) alone in decreasing both nausea and vomiting. Even with triple therapy, just over 50% of patients were nauseous and 20% vomited within the first 36 hours following surgery, and hospital LOS was unaffected. Thus, there is a pressing need for improved control of PONV in sleeve gastrectomy patients.

Acetaminophen (N-(4-hydroxyphenyl)acetamide; paracetamol) is a mild analgesic whose main, but not sole, mechanism of action is thought to arise from inhibition of the cyclooxygenase pathway; the intravenous (iv) formulation (acetaminophen iv; ACP-iv) received US Food and Drug Administration (FDA) approval in November 2010 but has been available in Europe since 2002. It is approved by the FDA for the management of mild to moderate pain as a single agent and the management of moderate to severe pain with adjunctive opioid analgesics. Recently, two meta-analyses have evaluated the use of ACP-iv in the postoperative period for its efficacy in preventing postoperative pain [45] or reducing PONV [46]. In the study by De Oliveria et al., ACP-iv administration was found to significantly reduce postoperative pain, opioid consumption, and PONV. Similarly, the study by Apfel and colleagues indicated that iv-ACP, when administered prophylactically, reduced PONV as a consequence of improved pain control. With direct relevance to sleeve gastrectomy patients, a retrospective analysis of patients undergoing bariatric surgery (sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass) found that ACP-iv administration reduced opiate consumption and hospital LOS.

The investigators hypothesize that administration of ACP-iv in the perioperative period will reduce hospital LOS in sleeve gastrectomy subjects and will be associated with a reduction in hospital costs. The secondary hypothesis is that administration of ACP-iv will reduce PONV and improve subject satisfaction scores in the same subject population.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective, Double Blind, Placebo Control, Study of Acetaminophen iv on Hospital Length of Stay in Morbidly Obese Individuals Undergoing Elective Laparoscopic Sleeve Gastrectomy
Actual Study Start Date : February 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
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
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
Other Name: Normal Saline

Active Comparator: Randomized
Subjects randomized into the active treatment group will receive intravenous acetaminophen
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
Other Name: Ofirmev




Primary Outcome Measures :
  1. Quality of Recovery-15 Patient Survey [ Time Frame: Patients will be followed for the duration of hospital stay, expected average of 3 days. ]
    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.


Secondary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: Participants will be followed for the duration of hospital stay, expected average of 3 days. ]
    Monitoring the length of hospital stay after undergoing surgery

  2. Hospital Costs [ Time Frame: Costs incurred during hospital stay, expected average of 3 days. ]
    Accessing billing codes/hospital costs for each enrolled subject from the time they are admitted until they are discharged from the hospital.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452320


Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Peter A Goldstein, MD Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02452320     History of Changes
Other Study ID Numbers: 1503016056
First Posted: May 22, 2015    Key Record Dates
Results First Posted: April 20, 2018
Last Update Posted: April 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not be making IPD available

Keywords provided by Weill Medical College of Cornell University:
bariatric
Post-operative nausea and vomiting
laparoscopic Sleeve gastrectomy
intravenous acetaminophen

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics