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Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476280
First Posted: November 22, 2011
Last Update Posted: November 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Soo Kyoung Park, Incheon St.Mary's Hospital
  Purpose
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: 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

Resource links provided by NLM:


Further study details as provided by Soo Kyoung Park, 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

  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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


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

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 Submitted: November 15, 2011
First Posted: November 22, 2011
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Soo Kyoung Park, Incheon St.Mary's Hospital:
antiemetics
ramosetron
palonosetron
PONV(postoperative nausea and vomiting)

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Palonosetron
Ramosetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents