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

Not Applicable

Completed

• Conditions: Laparoscopic Marsupialization of Renal Cyst
• Interventions: Drug: Ondansetron; Drug: Normal saline inj; Drug: Ramosetron; Drug: Palonosetron

• Registration Number: NCT01169805
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Study Start: 2010-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ONSERAN	Ondansetron	-
normal saline	Normal saline inj	-
NASEA	Ramosetron	-
ALOXI	Palonosetron	-

Primary Outcome Measures

Name	Time	Method
severity of nausea	during 73 hours after surgery
the number of vomiting	during 73 hours after surgery

Trial Locations

Locations (1)

Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of