Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo Kyoung Park, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01476280
First received: November 15, 2011
Last updated: November 17, 2011
Last verified: November 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • severity of nausea for 48 hours after surgery [ Time Frame: for 48 hours after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Soo Kyoung Park, Clinical professor, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT01476280     History of Changes
Other Study ID Numbers: OC11MISI0027
Study First Received: November 15, 2011
Last Updated: November 17, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 18, 2014