Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery

NCT ID: NCT01169805

Last Updated: 2011-11-18

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

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-06-30

Brief Summary

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The aim of this prospective randomized controlled study was to compare the prophylactic effects of intravenous single dose of ondansetron, ramosetron, and palonosetron on PCA-related nausea and vomiting after urologic laparoscopic surgery.

Detailed Description

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Conditions

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Laparoscopic Marsupialization of Renal Cyst

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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ONSERAN

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

Ondansetron/single injection/4 mg/IV

NASEA

Group Type EXPERIMENTAL

Ramosetron

Intervention Type DRUG

Ramosetron HCl/single injection/0.3mg/IV

ALOXI

Group Type EXPERIMENTAL

Palonosetron

Intervention Type DRUG

Palonosetron HCl/single injection/0.075mg/IV

normal saline

Group Type PLACEBO_COMPARATOR

Normal saline inj

Intervention Type DRUG

normal saline injection 2ml

Interventions

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Ondansetron

Ondansetron/single injection/4 mg/IV

Intervention Type DRUG

Ramosetron

Ramosetron HCl/single injection/0.3mg/IV

Intervention Type DRUG

Palonosetron

Palonosetron HCl/single injection/0.075mg/IV

Intervention Type DRUG

Normal saline inj

normal saline injection 2ml

Intervention Type DRUG

Other Intervention Names

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ONSERAN NASEA ALOXI

Eligibility Criteria

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Inclusion Criteria

* ASA I or II
* Patients aged (20-65 yr) Undergoing Laparoscopic Nephrectomy
* Patients who want a patient-controlled IV analgesia (IV-PCA)

Exclusion Criteria

* History of allergy or hypersensitivity to 5-HT3 antagonist
* History of severe postoperative nausea/vomiting
* Prolonged QT interval on preoperative EKG
* Hypokalemia, Hypomagnesemia
* Intestinal obstruction
* Pregnant female or breast feeding mother
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Hae Keum Kil

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2010-0176

Identifier Type: -

Identifier Source: org_study_id