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Completed

NCT Number: NCT01876290

Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinique de la Baie des Citrons

Nouméa, 98800, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone and Ondansetron

Drug

Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting

Placebo

Drug

Placebo

Primary outcomes

  1. Postoperative nausea or vomiting

    Time frame: 24 hours

    Severe nausea (> to 4 on a 0-10 visual analogue scale) or vomiting

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Should we Associate Dexamethasone and Ondansetron to Closed-loop Anesthesia to Reduce the Incidence of Postoperative Nausea and Vomiting After Bariatric Surgery?

Acronym: Loop-NVPO

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jun 12, 2013
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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