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

This study has been completed.
Information provided by (Responsible Party):
Hopital Foch Identifier:
First received: May 29, 2013
Last updated: May 22, 2015
Last verified: May 2015
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)

Enrollment: 122
Study Start Date: May 2013
Study Completion Date: March 2015
Primary Completion Date: January 2014 (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
Placebo Comparator: Placebo
Each patient will receive placebo instead of Dexamethasone and Ondansetron
Drug: 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.


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

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
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Please refer to this study by its identifier: NCT01876290

Clinique de la Baie des Citrons
Nouméa, France, 98800
Sponsors and Collaborators
Hopital Foch
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

Responsible Party: Hopital Foch Identifier: NCT01876290     History of Changes
Other Study ID Numbers: 2012/14 
Study First Received: May 29, 2013
Last Updated: May 22, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hopital Foch:

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
BB 1101
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Anxiety Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antipsychotic Agents
Autonomic Agents
Central Nervous System Depressants
Dermatologic Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents processed this record on May 26, 2016