Comparison of two drugs to prevent nausea and vomiting after surgery for removing the gallbladder
Phase 4
Recruiting
- Conditions
- Calculus of bile duct with cholecystitis, postoperative nausea and vomiting
- Registration Number
- RBR-4mjv6r
- Lead Sponsor
- Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Adult patients undergoing elective laparoscopic cholecystectomy; both genders; 18 to 65 years old; physical status I and II according to American Society of Anesthesiology (ASA)
Exclusion Criteria
Use of antiemetic drugs for 48 hours before surgery; those with hiatal hernia
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative nausea and/or vomiting incidence, verified by clinical observation and reported as yes or no, according to the presence of the symptom. The noninferiority will be 15%, meaning that the superior limit of the confidence interval for the incidence of nausea and vomiting in palonosetrona group will have to be less than 15% to accept the noninferiority hypothesis.
- Secondary Outcome Measures
Name Time Method Total dose of dimenhydrinate (rescue medication) used, verified by its administration (yes or no), reported as the need of use. It is expected that 30 doses of dimenhydrinate in each group will be administered.