Postoperative Nausea and Vomiting
Conditions
Keywords
nausea and vomiting, postoperative, emesis, postoperative
Brief summary
The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies.
Detailed description
Postoperative nausea and vomiting (PONV) is a common anesthetic complication that occurs in approximately 30% of the surgical population and can reach up to 70% in high risk patients for PONV. Advances have been made to prevent PONV, but the incidence is still high in certain groups of patients. In high risk patients, pharmacologic intervention should consist of multimodal therapy, targeting different mechanisms of action. The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies. METHODS: this is a randomized and double blind clinical trial. Female high-risk patients for PONV(Apfel score 3 or 4) scheduled for mastectomy that agree with the study and signed the informed consent, are randomly distributed into one of two groups: Group A, aprepitant 80 mg per os one hour before the surgery and Group B will receive placebo by the same route one hour before surgery, in a blinded way. After induction of anesthesia, dexamethasone 4 mg and palonosetron 0,075mg are intravenously administered to all patients. After the end of the surgery, a patient-controlled analgesia (PCA) device will be intravenously inserted in all patients. In the postoperative period, patients will be evaluated for nausea, vomiting and pain intensity in the recovery room and after 24 hours
Interventions
DRUGAprepitant
aprepitant will be administered in preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively
DRUGPlacebo
Placebo will be administered in the preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively
DRUGDexamethasone
Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* patients submitted to breast cancer surgery * non smokers
Exclusion criteria
* any contraindication to one of the drugs * mental disease * inability to understand the method or refusal to participate in the research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postoperative nausea and vomiting | 24 hours | intensity of nausea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain measured by Verbal and descriptive scale | 24 hours | pain intensity in the first 24 hours after surgery |
Countries
Brazil
Contacts
Primary ContactAngela Sousa, phD
Outcome results
None listed