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Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

A Randomized Double Blind Study to Evaluate Efficacy of Ramosetron and Palonosetron for Prevention of Postoperative Nausea and Vomiting After Gynaecological Laparoscopic Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01476280
Enrollment
100
Registered
2011-11-22
Start date
2011-05-31
Completion date
2011-08-31
Last updated
2011-11-22

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

Conditions

Postoperative Nausea and Vomiting

Keywords

antiemetics, ramosetron, palonosetron, PONV(postoperative nausea and vomiting)

Brief summary

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.

Interventions

DRUGpalonosetron

0.075mg immediately before induction of anesthesia

DRUGRamosetron

0.3mg immediately before induction of anesthesia

Sponsors

Incheon St.Mary's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative nausea and vomiting for 48 hours after surgeryfor 48 hours after surgery

Secondary

MeasureTime frame
severity of nausea for 48 hours after surgeryfor 48 hours after surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026