Clinical trial NCT01876290: Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting
Official title: Should we Associate Dexamethasone and Ondansetron to Closed-loop Anesthesia to Reduce the Incidence of Postoperative Nausea and Vomiting After Bariatric Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: Anesthesiology
Complications
Closed-loop
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18-75 years
* 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:

* Pregnant, breast feeding women
* Allergy
* Contraindication to dexamethasone
* Contraindication to ondansetron
* Contraindication to propofol, remifentanil, morphine, ketoprofen
* Limit to the use of bispectral index

Primary outcomes:
measure: Postoperative nausea or vomiting
timeFrame: 24 hours
Secondary outcomes:
measure: incidence of nausea
timeFrame: one day after anesthesia
measure: incidence of vomiting
timeFrame: one day after anesthesia
measure: rescue treatment
timeFrame: one day after anesthesia
measure: pain
timeFrame: one day after anesthesia
measure: sedation
timeFrame: one day after surgery
Other outcomes:
Locations:
city: Nouméa
country: France
facility: Clinique de la Baie des Citrons
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.