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Status unknownNCT01482468Updated Mar 23, 2012

Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting

An interventional study of continuous infusion of palonosetron added to prophylactic single injection of palonosetron and continuous infusion of normal saline added to prophylactic single injection of palonosetron in Postoperative Nausea and Vomiting, sponsored by Incheon St.Mary's Hospital. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-03-23.

Sponsored by Incheon St.Mary's Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
20 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Postoperative Nausea and Vomiting
03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's planned enrollment of 132 is above the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Incheon St.Mary's Hospital is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
132 participants (estimated)

Study arms

  • Active comparator
    continuous infusion

    continuous infusion of palonosetron added to prophylactic single injection of palonosetron

    Drug: continuous infusion of palonosetron added to prophylactic single injection of palonosetron

  • Placebo comparator
    singel injection

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

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

Interventions

  • Drugcontinuous 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

  • Drugcontinuous infusion of normal saline added to prophylactic single injection of palonosetron

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

06

What researchers measure

Primary outcomes

  1. incidence of postoperative nausea and vomiting

    Time frame: 24 hours after surgery

Secondary outcomes

  1. severity of nausea

    Time frame: for 24 hours after sugery

07

Study locations

1 of 1 sites recruiting
  • Incheon St Mary's hospital
    Incheon, 403-720, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01482468
Lead sponsor
Incheon St.Mary's Hospital
Responsible party
Soo Kyoung Park (Clnical professor, Incheon St.Mary's Hospital) — Principal investigator
First posted
Nov 30, 2011
Start date
Mar 2012
Primary completion
Jul 2012 (estimated)
Completion
Jul 2012 (estimated)
Last update
Mar 23, 2012

Study contacts

Soo Kyoung Park
Contact
hardmong@korea.com
82-32-280-5410

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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