Continuous Infusion of Palonosetron for Preventing of Postoperative Nausea and Vomiting

Not Applicable

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: continuous infusion of palonosetron added to prophylactic single injection of palonosetron; Drug: continuous infusion of normal saline added to prophylactic single injection of palonosetron

• Registration Number: NCT01482468
• Lead Sponsor: Incheon St.Mary's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-11-30
• Status Verified: 2012-03
• Study Start: 2012-03
• Last Update Submitted: 2012-03-21
• Last Update Posted: 2012-03-23
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous infusion	continuous infusion of palonosetron added to prophylactic single injection of palonosetron	continuous infusion of palonosetron added to prophylactic single injection of palonosetron
singel injection	continuous infusion of normal saline added to prophylactic single injection of palonosetron	continuous infusion of normal saline added to prophylactic single injection of palonosetron

Primary Outcome Measures

Name	Time	Method
incidence of postoperative nausea and vomiting	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
severity of nausea	for 24 hours after sugery

Trial Locations

Locations (1)

Incheon St Mary's hospital; 🇰🇷 Incheon, Korea, Republic of