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Palonosetron Versus Ramosetron for the Prevention of Postoperative Nausea and Vomiting

NCT ID: NCT01476280

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Nausea and Vomiting

Keywords

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antiemetics ramosetron palonosetron PONV(postoperative nausea and vomiting)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Palonosetron

Group Type SHAM_COMPARATOR

palonosetron

Intervention Type DRUG

0.075mg immediately before induction of anesthesia

Ramosetron

Group Type SHAM_COMPARATOR

Ramosetron

Intervention Type DRUG

0.3mg immediately before induction of anesthesia

Interventions

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palonosetron

0.075mg immediately before induction of anesthesia

Intervention Type DRUG

Ramosetron

0.3mg immediately before induction of anesthesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Incheon St.Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Kyoung Park

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo Kyoung Park

Role: PRINCIPAL_INVESTIGATOR

Incheon St.Mary's Hospital

Locations

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Incheon St. Mary's hospital

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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OC11MISI0027

Identifier Type: -

Identifier Source: org_study_id