Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting

March 21, 2012 updated by: Soo Kyoung Park, Incheon St.Mary's Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of postoperative nausea and vomiting
Time Frame: 24 hours after surgery
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
severity of nausea
Time Frame: for 24 hours after sugery
for 24 hours after sugery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incheon St.Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Estimate)

March 23, 2012

Last Update Submitted That Met QC Criteria

March 21, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OC11MISI0109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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