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Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
palonosetron
Ramosetron
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 focused on measuring antiemetics, ramosetron, palonosetron, PONV(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 hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Sham Comparator

Arm Label

Palonosetron

Ramosetron

Arm Description

Outcomes

Primary Outcome Measures

Incidence of postoperative nausea and vomiting for 48 hours after surgery

Secondary Outcome Measures

severity of nausea for 48 hours after surgery

Full Information

First Posted
November 15, 2011
Last Updated
November 17, 2011
Sponsor
Incheon St.Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01476280
Brief Title
Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
antiemetics, ramosetron, palonosetron, PONV(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
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Palonosetron
Arm Type
Sham Comparator
Arm Title
Ramosetron
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
palonosetron
Intervention Description
0.075mg immediately before induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Intervention Description
0.3mg immediately before induction of anesthesia
Primary Outcome Measure Information:
Title
Incidence of postoperative nausea and vomiting for 48 hours after surgery
Time Frame
for 48 hours after surgery
Secondary Outcome Measure Information:
Title
severity of nausea for 48 hours after surgery
Time Frame
for 48 hours after surgery

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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Kyoung Park
Organizational Affiliation
Incheon St.Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Incheon St. Mary's hospital
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of

12. IPD Sharing Statement

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Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

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