Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting
NCT ID: NCT01876290
Last Updated: 2016-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
122 participants
INTERVENTIONAL
2013-05-31
2015-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dexamethasone and Ondansetron
Each patient will receive Dexamethasone and Ondansetron
Dexamethasone and Ondansetron
Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting
Placebo
Each patient will receive placebo instead of Dexamethasone and Ondansetron
Placebo
Placebo
Interventions
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Dexamethasone and Ondansetron
Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* Allergy
* Contraindication to dexamethasone
* Contraindication to ondansetron
* Contraindication to propofol, remifentanil, morphine, ketoprofen
* Limit to the use of bispectral index
18 Years
75 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Marc Fischler, MD
Role: STUDY_CHAIR
Hôpital Foch
Locations
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Clinique de la Baie des Citrons
Nouméa, , France
Countries
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References
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Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
Song JW, Park EY, Lee JG, Park YS, Kang BC, Shim YH. The effect of combining dexamethasone with ondansetron for nausea and vomiting associated with fentanyl-based intravenous patient-controlled analgesia. Anaesthesia. 2011 Apr;66(4):263-7. doi: 10.1111/j.1365-2044.2011.06648.x.
Bataille A, Letourneulx JF, Charmeau A, Lemedioni P, Leger P, Chazot T, Le Guen M, Diemunsch P, Fischler M, Liu N. Impact of a prophylactic combination of dexamethasone-ondansetron on postoperative nausea and vomiting in obese adult patients undergoing laparoscopic sleeve gastrectomy during closed-loop propofol-remifentanil anaesthesia: A randomised double-blind placebo-controlled study. Eur J Anaesthesiol. 2016 Dec;33(12):898-905. doi: 10.1097/EJA.0000000000000427.
Other Identifiers
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2012-001486-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2012/14
Identifier Type: -
Identifier Source: org_study_id