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The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT01041183
Recruitment Status : Unknown
Verified November 2009 by Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2009
Last Update Posted : December 31, 2009
Sponsor:
Information provided by:
Seoul National University Bundang Hospital

Brief Summary:
Patients undergoing general anesthesia for laparoscopic cholecystectomy have a high risk of postoperative nausea and vomiting (PONV). The investigators investigated the effect of oral and IV ramosetron on PONV prophylaxis after laparoscopic cholecystectomy.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Laparoscopic Cholecystectomy Drug: intravenous ramosetron Drug: oral ramosetron Drug: oral and IV ramosetron Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : November 2009
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: group I
0.3 mg IV ramosetron
Drug: intravenous ramosetron
0.3 mg IV ramosetron (group I)
Active Comparator: group II
0.1 mg oral ramosetron
Drug: oral ramosetron
0.1 mg oral ramosetron (group II)
Active Comparator: group III
0.1 mg oral ramosetron plus 0.3 mg IV ramosetron
Drug: oral and IV ramosetron
0.1 mg oral ramosetron plus 0.3 mg IV ramosetron (group III).



Primary Outcome Measures :
  1. Incidence of PONV [ Time Frame: postoperative 0-48 h ]


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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II patients, 25-65 years, electivelaparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

  • GI disease, pregnant or menstruating, history of motion sickness and/or postoperative emesis, antiemetics within 24 h before surgery

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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): NCT01041183


Contacts
Contact: Jung-Hee Ryu, Ph.D 82-31-787-7497 jinaryu@lycos.co.kr

Locations
Korea, Republic of
Jung-Hee Ryu Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Jung-Hee Ryu, Ph.D    82-31-787-7497    jinaryu@lycos.co.kr   
Sponsors and Collaborators
Seoul National University Bundang Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01041183     History of Changes
Other Study ID Numbers: nasea-LC
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: December 31, 2009
Last Verified: November 2009

Keywords provided by Seoul National University Bundang Hospital:
Oral plus IV ramosetron may be more effective than
IV ramosetron and oral ramosetron for the prophylaxis of
PONV after laparoscopic cholecystectomy

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action