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The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01041183
First received: December 30, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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 Intervention
Nausea
Vomiting
Laparoscopic Cholecystectomy
 Drug: intravenous ramosetron
Drug: oral ramosetron
Drug: oral and IV ramosetron

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Incidence of PONV [ Time Frame: postoperative 0-48 h ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Seoul National University Bundang Hospital

Additional 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
Study First Received: December 30, 2009
Last Updated: December 30, 2009
Health Authority: Korea: Institutional Review Board

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:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013