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Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

This study has been completed.
Information provided by (Responsible Party):
Soo Kyoung Park, Incheon St.Mary's Hospital Identifier:
First received: November 15, 2011
Last updated: November 17, 2011
Last verified: November 2011
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.

Condition Intervention
Postoperative Nausea and Vomiting
Drug: palonosetron
Drug: Ramosetron

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Double Blind Study to Evaluate Efficacy of Ramosetron and Palonosetron for Prevention of Postoperative Nausea and Vomiting After Gynaecological Laparoscopic Surgery

Resource links provided by NLM:

Further study details as provided by Incheon St.Mary's Hospital:

Primary Outcome Measures:
  • Incidence of postoperative nausea and vomiting for 48 hours after surgery [ Time Frame: for 48 hours after surgery ]

Secondary Outcome Measures:
  • severity of nausea for 48 hours after surgery [ Time Frame: for 48 hours after surgery ]

Enrollment: 100
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Palonosetron Drug: palonosetron
0.075mg immediately before induction of anesthesia
Sham Comparator: Ramosetron Drug: Ramosetron
0.3mg immediately before induction of anesthesia


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01476280

Korea, Republic of
Incheon St. Mary's hospital
Incheon, Korea, Republic of, 403-720
Sponsors and Collaborators
Incheon St.Mary's Hospital
Principal Investigator: Soo Kyoung Park Incheon St.Mary's Hospital
  More Information

Responsible Party: Soo Kyoung Park, Clinical professor, Incheon St.Mary's Hospital Identifier: NCT01476280     History of Changes
Other Study ID Numbers: OC11MISI0027
Study First Received: November 15, 2011
Last Updated: November 17, 2011

Keywords provided by Incheon St.Mary's Hospital:
PONV(postoperative nausea and vomiting)

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2017