NCT01041183

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2009

Completed
Last Updated

December 31, 2009

Status Verified

November 1, 2009

Enrollment Period

1 month

First QC Date

December 30, 2009

Last Update Submit

December 30, 2009

Conditions

NauseaVomitingLaparoscopic Cholecystectomy

Keywords

Oral plus IV ramosetron may be more effective thanIV ramosetron and oral ramosetron for the prophylaxis ofPONV after laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of PONV

    postoperative 0-48 h

Study Arms (3)

group I

ACTIVE COMPARATOR

0.3 mg IV ramosetron

Drug: intravenous ramosetron

group II

ACTIVE COMPARATOR

0.1 mg oral ramosetron

Drug: oral ramosetron

group III

ACTIVE COMPARATOR

0.1 mg oral ramosetron plus 0.3 mg IV ramosetron

Drug: oral and IV ramosetron

Interventions

intravenous ramosetronDRUG

0.3 mg IV ramosetron (group I)

group I
oral ramosetronDRUG

0.1 mg oral ramosetron (group II)

group II
oral and IV ramosetronDRUG

0.1 mg oral ramosetron plus 0.3 mg IV ramosetron (group III).

group III

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jung-Hee Ryu

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21856001DERIVED

MeSH Terms

Conditions

NauseaVomiting

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Jung-Hee Ryu, Ph.D

CONTACT

82-31-787-7497jinaryu@lycos.co.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2009

First Posted

December 31, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2009

Last Updated

December 31, 2009

Record last verified: 2009-11

Locations

KR(1)