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