Dexamethasone and Ondansetron Versus Placebo for Postoperative Nausea and Vomiting

Study Overview
=================
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.

Official Title
-----------------
Should we Associate Dexamethasone and Ondansetron to Closed-loop Anesthesia to Reduce the Incidence of Postoperative Nausea and Vomiting After Bariatric Surgery?

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Dexamethasone and Ondansetron
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone and Ondansetron<br>Each patient will receive Dexamethasone and Ondansetron | Drug: Dexamethasone and Ondansetron<br>* Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting<br>|
| Placebo Comparator: Placebo<br>Each patient will receive placebo instead of Dexamethasone and Ondansetron | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea or vomiting | Severe nausea (> to 4 on a 0-10 visual analogue scale) or vomiting | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of nausea | incidence of nausea with delay of occurrence and severity (0-10 visual analogue scale) | one day after anesthesia | 
| incidence of vomiting | incidence of vomiting with delay of occurrence | one day after anesthesia | 
| rescue treatment | use of rescue treatment for PONV | one day after anesthesia | 
| pain | postoperative pain score (0-10 visual analogue scale) | one day after anesthesia | 
| sedation | postoperative sedation (0-10 visual analogue scale) | one day after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesiology, Complications, Closed-loop