The Effect of Oral and Intravenous Ramosetron During Laparoscopic Cholecystectomy

NCT ID: NCT01041183

Last Updated: 2009-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nausea Vomiting Laparoscopic Cholecystectomy

Keywords

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Oral plus IV ramosetron may be more effective than IV ramosetron and oral ramosetron for the prophylaxis of PONV after laparoscopic cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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group I

0.3 mg IV ramosetron

Group Type ACTIVE_COMPARATOR

intravenous ramosetron

Intervention Type DRUG

0.3 mg IV ramosetron (group I)

group II

0.1 mg oral ramosetron

Group Type ACTIVE_COMPARATOR

oral ramosetron

Intervention Type DRUG

0.1 mg oral ramosetron (group II)

group III

0.1 mg oral ramosetron plus 0.3 mg IV ramosetron

Group Type ACTIVE_COMPARATOR

oral and IV ramosetron

Intervention Type DRUG

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

Interventions

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intravenous ramosetron

0.3 mg IV ramosetron (group I)

Intervention Type DRUG

oral ramosetron

0.1 mg oral ramosetron (group II)

Intervention Type DRUG

oral and IV ramosetron

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Bundang Hospital

Locations

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Jung-Hee Ryu

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung-Hee Ryu, Ph.D

Role: CONTACT

Phone: 82-31-787-7497

Email: [email protected]

Facility Contacts

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Jung-Hee Ryu, Ph.D

Role: primary

References

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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.

Reference Type DERIVED
PMID: 21856001 (View on PubMed)

Other Identifiers

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nasea-LC

Identifier Type: -

Identifier Source: org_study_id