Clinique de la Baie des Citrons
Nouméa, 98800, France
NCT Number: NCT01876290
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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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Nouméa, 98800, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting
Placebo
Time frame: 24 hours
Severe nausea (> to 4 on a 0-10 visual analogue scale) or vomiting
Time frame: one day after anesthesia
incidence of nausea with delay of occurrence and severity (0-10 visual analogue scale)
Time frame: one day after anesthesia
incidence of vomiting with delay of occurrence
Time frame: one day after anesthesia
use of rescue treatment for PONV
Time frame: one day after anesthesia
postoperative pain score (0-10 visual analogue scale)
Time frame: one day after surgery
postoperative sedation (0-10 visual analogue scale)
Hopital Foch
Other
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
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