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

Primary Purpose

Laparoscopic Marsupialization of Renal Cyst

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ondansetron
Ramosetron
Palonosetron
Normal saline inj
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laparoscopic Marsupialization of Renal Cyst

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ONSERAN

NASEA

ALOXI

normal saline

Arm Description

Outcomes

Primary Outcome Measures

severity of nausea
the number of vomiting

Secondary Outcome Measures

Full Information

First Posted
July 22, 2010
Last Updated
November 16, 2011
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01169805
Brief Title
Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery
Official Title
Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Marsupialization of Renal Cyst

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ONSERAN
Arm Type
Experimental
Arm Title
NASEA
Arm Type
Experimental
Arm Title
ALOXI
Arm Type
Experimental
Arm Title
normal saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
ONSERAN
Intervention Description
Ondansetron/single injection/4 mg/IV
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Other Intervention Name(s)
NASEA
Intervention Description
Ramosetron HCl/single injection/0.3mg/IV
Intervention Type
Drug
Intervention Name(s)
Palonosetron
Other Intervention Name(s)
ALOXI
Intervention Description
Palonosetron HCl/single injection/0.075mg/IV
Intervention Type
Drug
Intervention Name(s)
Normal saline inj
Intervention Description
normal saline injection 2ml
Primary Outcome Measure Information:
Title
severity of nausea
Time Frame
during 73 hours after surgery
Title
the number of vomiting
Time Frame
during 73 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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