Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

Incheon St.Mary's Hospital

Status: Completed

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Ramosetron; Drug: palonosetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01476280

OC11MISI0027

Details and patient eligibility

About

Ramosetron and palonosetron are more recently developed 5-hydroxytryptamine type 3 receptor antagonists and this randomized double blind study was designed to compare efficacy of ramosetron and palonosetron to prevent postoperative nausea and vomiting. Investigator hypothesized that palonosetron would have stronger and longer lasting antiemetic effect compared with ramosetron and evaluated the patients for the first 48 hours after surgery.

Enrollment: 100 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA Physical Status 1 or 2
• Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion criteria

• Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
• Vomiting or retching in the 24 h preceding surgery
• Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
• Ongoing vomiting from gastrointestinal disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Palonosetron

Sham Comparator group

Treatment:

Drug: palonosetron

Ramosetron

Sham Comparator group

Treatment:

Drug: Ramosetron