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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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Yonsei University

Status

Completed

Conditions

Laparoscopic Marsupialization of Renal Cyst

Treatments

Drug: Ondansetron
Drug: Palonosetron
Drug: Normal saline inj
Drug: Ramosetron

Study type

Interventional

Funder types

Other

Identifiers

NCT01169805
4-2010-0176

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

Female

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

105 participants in 4 patient groups, including a placebo group

ONSERAN
Experimental group
Treatment:
Drug: Ondansetron
NASEA
Experimental group
Treatment:
Drug: Ramosetron
ALOXI
Experimental group
Treatment:
Drug: Palonosetron
normal saline
Placebo Comparator group
Treatment:
Drug: Normal saline inj

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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