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The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

Primary Purpose

Nausea, Vomiting, Laparoscopic Cholecystectomy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
intravenous ramosetron
oral ramosetron
oral and IV ramosetron
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea focused on measuring Oral plus IV ramosetron may be more effective than, IV ramosetron and oral ramosetron for the prophylaxis of, PONV after laparoscopic cholecystectomy

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jung-Hee RyuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

group I

group II

group III

Arm Description

0.3 mg IV ramosetron

0.1 mg oral ramosetron

0.1 mg oral ramosetron plus 0.3 mg IV ramosetron

Outcomes

Primary Outcome Measures

Incidence of PONV

Secondary Outcome Measures

Full Information

First Posted
December 30, 2009
Last Updated
December 30, 2009
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01041183
Brief Title
The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Laparoscopic Cholecystectomy
Keywords
Oral plus IV ramosetron may be more effective than, IV ramosetron and oral ramosetron for the prophylaxis of, PONV after laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group I
Arm Type
Active Comparator
Arm Description
0.3 mg IV ramosetron
Arm Title
group II
Arm Type
Active Comparator
Arm Description
0.1 mg oral ramosetron
Arm Title
group III
Arm Type
Active Comparator
Arm Description
0.1 mg oral ramosetron plus 0.3 mg IV ramosetron
Intervention Type
Drug
Intervention Name(s)
intravenous ramosetron
Intervention Description
0.3 mg IV ramosetron (group I)
Intervention Type
Drug
Intervention Name(s)
oral ramosetron
Intervention Description
0.1 mg oral ramosetron (group II)
Intervention Type
Drug
Intervention Name(s)
oral and IV ramosetron
Intervention Description
0.1 mg oral ramosetron plus 0.3 mg IV ramosetron (group III).
Primary Outcome Measure Information:
Title
Incidence of PONV
Time Frame
postoperative 0-48 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-Hee Ryu, Ph.D
Phone
82-31-787-7497
Email
jinaryu@lycos.co.kr
Facility Information:
Facility Name
Jung-Hee Ryu
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung-Hee Ryu, Ph.D
Phone
82-31-787-7497
Email
jinaryu@lycos.co.kr

12. IPD Sharing Statement

Citations:
PubMed Identifier
21856001
Citation
Ryu JH, Jeon YT, Hwang JW, Oh AY, Moon JY, Ro YJ, Kim CS, Chen C, Apfel CC, Do SH. Intravenous, oral, and the combination of intravenous and oral ramosetron for the prevention of nausea and vomiting after laparoscopic cholecystectomy: a randomized, double-blind, controlled trial. Clin Ther. 2011 Sep;33(9):1162-72. doi: 10.1016/j.clinthera.2011.07.018.
Results Reference
derived

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The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

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