NCT01169805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 18, 2011

Status Verified

November 1, 2011

Enrollment Period

10 months

First QC Date

July 22, 2010

Last Update Submit

November 16, 2011

Conditions

Laparoscopic Marsupialization of Renal Cyst

Outcome Measures

Primary Outcomes (2)

  • severity of nausea

    during 73 hours after surgery

  • the number of vomiting

    during 73 hours after surgery

Study Arms (4)

ONSERAN

EXPERIMENTAL
Drug: Ondansetron

NASEA

EXPERIMENTAL
Drug: Ramosetron

ALOXI

EXPERIMENTAL
Drug: Palonosetron

normal saline

PLACEBO COMPARATOR
Drug: Normal saline inj

Interventions

OndansetronDRUG

Ondansetron/single injection/4 mg/IV

Also known as: ONSERAN
ONSERAN
RamosetronDRUG

Ramosetron HCl/single injection/0.3mg/IV

Also known as: NASEA
NASEA
PalonosetronDRUG

Palonosetron HCl/single injection/0.075mg/IV

Also known as: ALOXI
ALOXI
Normal saline injDRUG

normal saline injection 2ml

normal saline

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

OndansetronramosetronPalonosetron

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingQuinuclidinesHeterocyclic Compounds, Bridged-RingIsoquinolines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 26, 2010

Study Start

August 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 18, 2011

Record last verified: 2011-11

Locations

KR(1)