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Clinical Trials/NCT01482468
NCT01482468UnknownNot Applicable

Effect of Continuous Infusion of Palonosetron Following Single Prophylactic Injection of Palonosetron for Preventing Postoperative Nausea and Vomiting

Incheon St.Mary's Hospital1 site in 1 country132 target enrollmentStarted: March 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
132
Locations
1
Primary Endpoint
incidence of postoperative nausea and vomiting
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

continuous infusion

Active Comparator

continuous infusion of palonosetron added to prophylactic single injection of palonosetron

Intervention: continuous infusion of palonosetron added to prophylactic single injection of palonosetron (Drug)

singel injection

Placebo Comparator

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

Intervention: continuous infusion of normal saline added to prophylactic single injection of palonosetron (Drug)

Outcomes

Primary Outcomes

incidence of postoperative nausea and vomiting

Time Frame: 24 hours after surgery

Secondary Outcomes

  • severity of nausea(for 24 hours after sugery)

Investigators

Sponsor
Incheon St.Mary's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Soo Kyoung Park

Clnical professor

Incheon St.Mary's Hospital

Study Sites (1)

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