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Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
continuous infusion of palonosetron added to prophylactic single injection of palonosetron
continuous infusion of normal saline added to prophylactic single injection of palonosetron
Sponsored by
Incheon St.Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Incheon St Mary's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

continuous infusion

singel injection

Arm Description

continuous infusion of palonosetron added to prophylactic single injection of palonosetron

continuous infusion of normal saline added to prophylactic single injection of palonosetron

Outcomes

Primary Outcome Measures

incidence of postoperative nausea and vomiting

Secondary Outcome Measures

severity of nausea

Full Information

First Posted
November 28, 2011
Last Updated
March 21, 2012
Sponsor
Incheon St.Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01482468
Brief Title
Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting
Official Title
Effect of Continuous Infusion of Palonosetron Following Single Prophylactic Injection of Palonosetron for Preventing Postoperative Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Incheon St.Mary's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
continuous infusion
Arm Type
Active Comparator
Arm Description
continuous infusion of palonosetron added to prophylactic single injection of palonosetron
Arm Title
singel injection
Arm Type
Placebo Comparator
Arm Description
continuous infusion of normal saline added to prophylactic single injection of palonosetron
Intervention Type
Drug
Intervention Name(s)
continuous infusion of palonosetron added to prophylactic single injection of palonosetron
Intervention Description
continuous infusion of palonosetron 0.00075 mg/hour after single injection of palonosetron 0.075mg
Intervention Type
Drug
Intervention Name(s)
continuous infusion of normal saline added to prophylactic single injection of palonosetron
Intervention Description
continuous infusion of normal saline after single injection of palonosetron 0.075mg
Primary Outcome Measure Information:
Title
incidence of postoperative nausea and vomiting
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
severity of nausea
Time Frame
for 24 hours after sugery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Kyoung Park
Phone
82-32-280-5410
Email
hardmong@korea.com
Facility Information:
Facility Name
Incheon St Mary's hospital
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Kyoung Park
Phone
82-32-280-5410
Email
hardmong@korea.com

12. IPD Sharing Statement

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Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting

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