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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hae Keum Kil, Yonsei University
ClinicalTrials.gov Identifier:
NCT01169805
First received: July 22, 2010
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Laparoscopic Marsupialization of Renal Cyst
 Drug: Ondansetron
Drug: Ramosetron
Drug: Palonosetron
Drug: Normal saline inj

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • severity of nausea [ Time Frame: during 73 hours after surgery ] [ Designated as safety issue: No ]
  • the number of vomiting [ Time Frame: during 73 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ONSERAN Drug: Ondansetron
Ondansetron/single injection/4 mg/IV
Other Name: ONSERAN
Experimental: NASEA Drug: Ramosetron
Ramosetron HCl/single injection/0.3mg/IV
Other Name: NASEA
Experimental: ALOXI Drug: Palonosetron
Palonosetron HCl/single injection/0.075mg/IV
Other Name: ALOXI
Placebo Comparator: normal saline Drug: Normal saline inj
normal saline injection 2ml

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169805

Locations
Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Hae Keum Kil, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01169805     History of Changes
Other Study ID Numbers: 4-2010-0176
Study First Received: July 22, 2010
Last Updated: November 16, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Ondansetron
Ramosetron
Palonosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
 Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 23, 2013