Laparoscopic Marsupialization of Renal CystNCT01169805

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

A study testing Ondansetron, Ramosetron and Palonosetron in people with Laparoscopic Marsupialization of Renal Cyst, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 20 to 65 years, women only
Conditions the study is for: Laparoscopic Marsupialization of Renal Cyst
What is being tested?: Ondansetron, Ramosetron and Palonosetron
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 105 participants
Where: 1 siteSouth Korea
Study dates: Aug 2010to Jun 2011
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Severance Hospital, Yonsei University College of Medicine
Seoul, 120-752

Other trials in South Korea

About this study

Conditions: Laparoscopic Marsupialization of Renal Cyst
Being tested: Ondansetron, Ramosetron, Palonosetron, Normal saline inj

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OndansetronDrug
Also called ONSERAN
Ondansetron/single injection/4 mg/IV
RamosetronDrug
Also called NASEA
Ramosetron HCl/single injection/0.3mg/IV
PalonosetronDrug
Also called ALOXI
Palonosetron HCl/single injection/0.075mg/IV
Normal saline injDrug
normal saline injection 2ml

Study groups in NCT01169805
Study group	Role	What they receive
ONSERAN	Experimental	Not described Receives: Drug: Ondansetron
NASEA	Experimental	Not described Receives: Drug: Ramosetron
ALOXI	Experimental	Not described Receives: Drug: Palonosetron
normal saline	Placebo comparator	Not described Receives: Drug: Normal saline inj

What is being measured

The primary outcome is the main question the study is designed to answer.

severity of nausea
Measured: during 73 hours after surgery
the number of vomiting
Measured: during 73 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jun 2011

First posted26 Jul 2010 (estimated)
Study startAug 2010
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Laparoscopic Marsupialization of Renal CystStudies of the same condition, open and under way.
More trials run by Yonsei UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01169805
Sponsor's protocol ID: 4-2010-0176
Status last verified: Nov 2011
First submitted: 22 Jul 2010
Last updated: 18 Nov 2011
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery
ClinicalTrials.gov ID: NCT01169805
Acronym / sponsor ID: 4-2010-0176
Conditions: Laparoscopic Marsupialization of Renal Cyst
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: Aug 2010
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 26 Jul 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, investigator)
Number of arms: 4

Arm	Type	Receives
ONSERAN	Experimental	Drug: Ondansetron
NASEA	Experimental	Drug: Ramosetron
ALOXI	Experimental	Drug: Palonosetron
normal saline	Placebo comparator	Drug: Normal saline inj

Who may qualify

Ages: 20 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OndansetronAlso: ONSERANOndansetron/single injection/4 mg/IV	Drug	ONSERAN
RamosetronAlso: NASEARamosetron HCl/single injection/0.3mg/IV	Drug	NASEA
PalonosetronAlso: ALOXIPalonosetron HCl/single injection/0.075mg/IV	Drug	ALOXI
Normal saline injnormal saline injection 2ml	Drug	normal saline

Primary outcome

severity of nausea
Time frame: during 73 hours after surgery
the number of vomiting
Time frame: during 73 hours after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2011.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ondansetron, Ramosetron and Palonosetron in people with Laparoscopic Marsupialization of Renal Cyst, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

severity of nausea (time frame: during 73 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01169805.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2011.