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Comparison of two drugs to prevent nausea and vomiting after surgery for removing the gallbladder

Palonosetron versus Ondansetron for Postoperative Nausea and Vomiting Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Noninferiority Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-4mjv6r
Enrollment
Unknown
Registered
2017-04-12
Start date
2017-01-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calculus of bile duct with cholecystitis, postoperative nausea and vomiting

Interventions

Experimental group: 106 patients undergoing laparoscopic cholecystectomy surgery will be given intravenous palonosetron 0.075 mg, before anesthesia induction. Control group: 106 patients undergoing la

Sponsors

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP
Lead Sponsor

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria: Use of antiemetic drugs for 48 hours before surgery; those with hiatal hernia

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactPaulo do Nascimento Junior

Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, UNESP

pnasc@fmb.unesp.br+55(14)38801414

Outcome results

None listed

Source: REBEC (via WHO ICTRP)