The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01041183
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Dec 1, 2009

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Incidence of PONV [postoperative 0-48 h]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Jung-Hee Ryu	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01041183
• Other Study ID Numbers: nasea-LC
• First Posted: Dec 31, 2009
• Last Update Posted: Dec 31, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: 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; Ramosetron

Study Results

No Results Posted as of Dec 31, 2009