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Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting

This study is currently recruiting participants.
Verified March 2012 by Incheon St.Mary's Hospital
Sponsor:
Information provided by (Responsible Party):
Soo Kyoung Park, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01482468
First received: November 28, 2011
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to determine whether continuous infusion of palonosetron after its prophylactic single injection can further reduce the incidence of postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery.


Condition Intervention
Postoperative Nausea and Vomiting
 Drug: continuous infusion of palonosetron added to prophylactic single injection of palonosetron
Drug: continuous infusion of normal saline added to prophylactic single injection of palonosetron

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: Effect of Continuous Infusion of Palonosetron Following Single Prophylactic Injection of Palonosetron for Preventing Postoperative Nausea and Vomiting

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • incidence of postoperative nausea and vomiting [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • severity of nausea [ Time Frame: for 24 hours after sugery ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: March 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: continuous infusion
continuous infusion of palonosetron added to prophylactic single injection of palonosetron
 Drug: continuous infusion of palonosetron added to prophylactic single injection of palonosetron
continuous infusion of palonosetron 0.00075 mg/hour after single injection of palonosetron 0.075mg
Placebo Comparator: singel injection
continuous infusion of normal saline added to prophylactic single injection of palonosetron
 Drug: continuous infusion of normal saline added to prophylactic single injection of palonosetron
continuous infusion of normal saline after single injection of palonosetron 0.075mg

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482468

Contacts
Contact: Soo Kyoung Park 82-32-280-5410 hardmong@korea.com

Locations
Korea, Republic of
Incheon St Mary's hospital Recruiting
Incheon, Korea, Republic of, 403-720
Contact: Soo Kyoung Park     82-32-280-5410     hardmong@korea.com    
Sponsors and Collaborators
Incheon St.Mary's Hospital
  More Information

No publications provided

Responsible Party: Soo Kyoung Park, Clnical professor, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT01482468     History of Changes
Other Study ID Numbers: OC11MISI0109
Study First Received: November 28, 2011
Last Updated: March 21, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
 Palonosetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013