Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting

NCT ID: NCT01482468

Last Updated: 2012-03-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to determine whether continuous infusion of palonosetron after its prophylactic single injection can further reduce the incidence of postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery.

Detailed Description

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Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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continuous infusion

continuous infusion of palonosetron added to prophylactic single injection of palonosetron

Group Type ACTIVE_COMPARATOR

continuous infusion of palonosetron added to prophylactic single injection of palonosetron

Intervention Type DRUG

continuous infusion of palonosetron 0.00075 mg/hour after single injection of palonosetron 0.075mg

singel injection

continuous infusion of normal saline added to prophylactic single injection of palonosetron

Group Type PLACEBO_COMPARATOR

continuous infusion of normal saline added to prophylactic single injection of palonosetron

Intervention Type DRUG

continuous infusion of normal saline after single injection of palonosetron 0.075mg

Interventions

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continuous infusion of palonosetron added to prophylactic single injection of palonosetron

continuous infusion of palonosetron 0.00075 mg/hour after single injection of palonosetron 0.075mg

Intervention Type DRUG

continuous infusion of normal saline added to prophylactic single injection of palonosetron

continuous infusion of normal saline after single injection of palonosetron 0.075mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA Physical Status 1 or 2
* Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion Criteria

* Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
* Vomiting or retching in the 24 h preceding surgery
* Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
* Ongoing vomiting from gastrointestinal disease
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Incheon St.Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Kyoung Park

Clnical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Incheon St Mary's hospital

Incheon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Soo Kyoung Park

Role: CONTACT

82-32-280-5410

Facility Contacts

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Soo Kyoung Park

Role: primary

82-32-280-5410

Other Identifiers

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OC11MISI0109

Identifier Type: -

Identifier Source: org_study_id

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