Postoperative Nausea and Vomiting
Conditions
Keywords
Anesthesiology, Complications, Closed-loop
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.
Interventions
Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting
DRUGPlacebo
Placebo
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea or vomiting | 24 hours | Severe nausea (\> to 4 on a 0-10 visual analogue scale) or vomiting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of nausea | one day after anesthesia | incidence of nausea with delay of occurrence and severity (0-10 visual analogue scale) |
| incidence of vomiting | one day after anesthesia | incidence of vomiting with delay of occurrence |
| rescue treatment | one day after anesthesia | use of rescue treatment for PONV |
| pain | one day after anesthesia | postoperative pain score (0-10 visual analogue scale) |
| sedation | one day after surgery | postoperative sedation (0-10 visual analogue scale) |
Countries
France
Outcome results
None listed