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Comparison of two drugs to prevent nausea and vomiting after surgery for reducing the stomach

Palonosetron versus ondansetron for postoperative nausea and vomiting prophylaxis in laparoscopic gastroplasty in morbid obese patients - a randomized controlled noninferiority trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-55mp5z
Enrollment
Unknown
Registered
2016-03-18
Start date
2015-11-15
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

Obesity, Postoperative Nausea and Vomiting

Interventions

Experimental group: 83 patients undergoing bariatric surgery will be given intravenous palonosetron 0.075 mg, before anesthesia induction. Control group: 83 patients undergoing bariatric surgery will
Drug

Sponsors

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

Eligibility

Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adult patients undergoing elective laparoscopic gastroplasty; both sexes; 20 to 65 years old; physical state I and II according to American Society of Anesthesiology (ASA); body mass index equal or higher than 35 kg/m2

Exclusion criteria

Exclusion criteria: Use of antiemetics for 48 hs 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. Expected incidence of nausea and/or vomiting is 25% of patients in each group.

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 40 doses of dimenhydrinate in each group will be administered.

Countries

Brazil

Contacts

Public ContactPaulo do Nascimento Junior

Faculdade de Medicina de Botucatu, UNESP

pnasc@fmb.unesp.br+55 (14) 3880 1414

Outcome results

None listed

Source: REBEC (via WHO ICTRP)