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Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

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ClinicalTrials.gov Identifier: NCT01476280
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Information provided by (Responsible Party):
Soo Kyoung Park, Incheon St.Mary's Hospital

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.

Condition or disease Intervention/treatment
Postoperative Nausea and Vomiting Drug: palonosetron Drug: Ramosetron

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : May 2011
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Palonosetron Drug: palonosetron
0.075mg immediately before induction of anesthesia
Sham Comparator: Ramosetron Drug: Ramosetron
0.3mg immediately before induction of anesthesia

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Soo Kyoung Park, Clinical professor, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT01476280     History of Changes
Other Study ID Numbers: OC11MISI0027
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Soo Kyoung Park, 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
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents