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

November 16, 2011 updated by: Hae Keum Kil, Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

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 Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Severance hospital, Yonsei university college of medicine

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: normal saline
Drug: Normal saline inj
normal saline injection 2ml
Experimental: ONSERAN
Drug: Ondansetron
Ondansetron/single injection/4 mg/IV
Other Names:
  • ONSERAN
Experimental: NASEA
Drug: Ramosetron
Ramosetron HCl/single injection/0.3mg/IV
Other Names:
  • NASEA
Experimental: ALOXI
Drug: Palonosetron
Palonosetron HCl/single injection/0.075mg/IV
Other Names:
  • ALOXI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
severity of nausea
Time Frame: during 73 hours after surgery
during 73 hours after surgery
the number of vomiting
Time Frame: during 73 hours after surgery
during 73 hours after surgery

Collaborators and Investigators

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

Sponsor

Yonsei University

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

August 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 22, 2010

First Submitted That Met QC Criteria

July 23, 2010

First Posted (Estimate)

July 26, 2010

Study Record Updates

Last Update Posted (Estimate)

November 18, 2011

Last Update Submitted That Met QC Criteria

November 16, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2010-0176

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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