A Phase 4 interventional study of Dexamethasone and Ondansetron and Placebo in Postoperative Nausea and Vomiting, sponsored by Hopital Foch. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-10-31.
Sponsored by Hopital Foch · Phase 4, Interventional, and Prevention
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.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 122 is close to the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each patient will receive Dexamethasone and Ondansetron
Drug: Dexamethasone and Ondansetron
Each patient will receive placebo instead of Dexamethasone and Ondansetron
Drug: Placebo
Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting
Placebo
Postoperative nausea or vomiting
Severe nausea (\> to 4 on a 0-10 visual analogue scale) or vomiting
Time frame: 24 hours
incidence of nausea
incidence of nausea with delay of occurrence and severity (0-10 visual analogue scale)
Time frame: one day after anesthesia
incidence of vomiting
incidence of vomiting with delay of occurrence
Time frame: one day after anesthesia
rescue treatment
use of rescue treatment for PONV
Time frame: one day after anesthesia
pain
postoperative pain score (0-10 visual analogue scale)
Time frame: one day after anesthesia
sedation
postoperative sedation (0-10 visual analogue scale)
Time frame: one day after surgery
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Hopital Foch