Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting (Loop-NVPO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hopital Foch
Sponsor:
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01876290
First received: May 29, 2013
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

The investigators want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.


Condition Intervention Phase
Postoperative Nausea and Vomiting
Drug: Dexamethasone and Ondansetron
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Should we Associate Dexamethasone and Ondansetron to Closed-loop Anesthesia to Reduce the Incidence of Postoperative Nausea and Vomiting After Bariatric Surgery?

Resource links provided by NLM:


Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Postoperative nausea or vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Severe nausea (> to 4 on a 0-10 visual analogue scale) or vomiting


Secondary Outcome Measures:
  • incidence of nausea [ Time Frame: one day after anesthesia ] [ Designated as safety issue: No ]
    incidence of nausea with delay of occurrence and severity (0-10 visual analogue scale)

  • incidence of vomiting [ Time Frame: one day after anesthesia ] [ Designated as safety issue: No ]
    incidence of vomiting with delay of occurrence

  • rescue treatment [ Time Frame: one day after anesthesia ] [ Designated as safety issue: No ]
    use of rescue treatment for PONV

  • pain [ Time Frame: one day after anesthesia ] [ Designated as safety issue: No ]
    postoperative pain score (0-10 visual analogue scale)

  • sedation [ Time Frame: one day after surgery ] [ Designated as safety issue: No ]
    postoperative sedation (0-10 visual analogue scale)


Estimated Enrollment: 120
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone and Ondansetron
Each patient will receive Dexamethasone and Ondansetron
Drug: Dexamethasone and Ondansetron
Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting
Other Name: Dexamethasone and Ondansetron
Placebo Comparator: Placebo
Each patient will receive placebo instead of Dexamethasone and Ondansetron
Drug: Placebo
Placebo
Other Name: Placebo

Detailed Description:

Obese patients having bariatric surgery have frequently postoperative nausea and vomiting (PONV). We want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.

Two groups to be studied: one will receive 4 mg dexamethasone at the end of the anesthetic induction and 4 mg ondansetron at the end of the surgical procedure, one will receive normal saline.

One hundred twenty consecutive patients meeting the inclusion and exclusion criteria and who give written informed consent to participate in the study will be randomly assigned to one of two experimental groups using a 1:1 ratio.

Patients will be continuously monitored in the post anesthesia care unit (PACU) and the medical floor for a total of 24 hours post operatively. Episodes of nausea, vomiting and administration of rescue therapy for either nausea or vomiting will be recorded and time stamped. In addition, severity of nausea will be evaluated by the patient using a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Rescue therapy for PONV episodes will consist of 4 mg ondansetron followed by 0.625 mg droperidol if necessary.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients aged 18-75 years
  • Scheduled for bariatric surgery under total intra-venous closed-loop anesthesia
  • Apfel score equal or greater than 2
  • Consenting to participate in the study

Exclusion Criteria:

  • Pregnant, breast feeding women
  • Allergy
  • Contraindication to dexamethasone
  • Contraindication to ondansetron
  • Contraindication to propofol, remifentanil, morphine, ketoprofen
  • Limit to the use of bispectral index
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876290

Contacts
Contact: Marc Fischler, MD 46252442 ext 00331 m.fischler@hopital-foch.org

Locations
France
Clinique de la Baie des Citrons Recruiting
Nouméa, France, 98800
Contact: Alain Charmeau, MD    687 261 866    charmeau@offratel.nc   
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

Publications:
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01876290     History of Changes
Other Study ID Numbers: 2012/14
Study First Received: May 29, 2013
Last Updated: December 13, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hopital Foch:
Anesthesiology
Complications
Closed-loop

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Ondansetron
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics

ClinicalTrials.gov processed this record on July 22, 2014