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

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ClinicalTrials.gov Identifier: NCT01876290
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Dexamethasone and Ondansetron Drug: Placebo Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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?
Study Start Date : May 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2015


Arm Intervention/treatment
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
Placebo




Primary Outcome Measures :
  1. Postoperative nausea or vomiting [ Time Frame: 24 hours ]
    Severe nausea (> to 4 on a 0-10 visual analogue scale) or vomiting


Secondary Outcome Measures :
  1. incidence of nausea [ Time Frame: one day after anesthesia ]
    incidence of nausea with delay of occurrence and severity (0-10 visual analogue scale)

  2. incidence of vomiting [ Time Frame: one day after anesthesia ]
    incidence of vomiting with delay of occurrence

  3. rescue treatment [ Time Frame: one day after anesthesia ]
    use of rescue treatment for PONV

  4. pain [ Time Frame: one day after anesthesia ]
    postoperative pain score (0-10 visual analogue scale)

  5. sedation [ Time Frame: one day after surgery ]
    postoperative sedation (0-10 visual analogue scale)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01876290


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT01876290     History of Changes
Other Study ID Numbers: 2012/14
2012-001486-32 ( EudraCT Number )
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by Hopital Foch:
Anesthesiology
Complications
Closed-loop

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Ondansetron
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents