Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting (Loop-NVPO)
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.
Postoperative Nausea and Vomiting
Drug: Dexamethasone and Ondansetron
|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?|
- 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
- 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)
|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)|
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
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01876290
|Contact: Marc Fischler, MD||46252442 ext email@example.com|
|Clinique de la Baie des Citrons||Recruiting|
|Nouméa, France, 98800|
|Contact: Alain Charmeau, MD 687 261 866 firstname.lastname@example.org|
|Study Chair:||Marc Fischler, MD||Hôpital Foch|