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

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ClinicalTrials.gov Identifier: NCT01169805
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : November 18, 2011
Sponsor:
Information provided by (Responsible Party):
Hae Keum Kil, 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.

Condition or disease Intervention/treatment Phase
Laparoscopic Marsupialization of Renal Cyst Drug: Ondansetron Drug: Ramosetron Drug: Palonosetron Drug: Normal saline inj Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, 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
Study Start Date : August 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. severity of nausea [ Time Frame: during 73 hours after surgery ]
  2. the number of vomiting [ Time Frame: during 73 hours after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169805


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

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Responsible Party: Hae Keum Kil, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01169805    
Other Study ID Numbers: 4-2010-0176
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: November 2011
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Palonosetron
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Serotonin 5-HT3 Receptor Antagonists