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NCT01041183 Clinical Trial

The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

Nausea Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01041183
Other study ID # nasea-LC
Secondary ID
Status Unknown status
Phase N/A
First received December 30, 2009
Last updated December 30, 2009
Start date November 2009

Study information
Verified date November 2009
Source Seoul National University Bundang Hospital
Contact Jung-Hee Ryu, Ph.D
Phone 82-31-787-7497
Email jinaryu@lycos.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 120
Est. completion date
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 25 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• intravenous ramosetron
0.3 mg IV ramosetron (group I)
• oral ramosetron
0.1 mg oral ramosetron (group II)
• oral and IV ramosetron
0.1 mg oral ramosetron plus 0.3 mg IV ramosetron (group III).

Locations
Country Name City State
Korea, Republic of Jung-Hee Ryu Seongnam-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of PONV postoperative 0-48 h
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