Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant

NCT ID: NCT02597907

Last Updated: 2017-04-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.

Detailed Description

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The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.

Study is performed during 24 hours after surgery.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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aprepitant plus palonosetron

aprepitant 80 mg palonosetron 0.075 mg

Group Type EXPERIMENTAL

aprepitant

Intervention Type DRUG

aprepitant 80 mg is given to all patients before surgery

palonosetron

Intervention Type DRUG

palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia

aprepitant plus ramosetron

aprepitant 80 mg ramosetron 0.3 mg

Group Type ACTIVE_COMPARATOR

aprepitant

Intervention Type DRUG

aprepitant 80 mg is given to all patients before surgery

Ramosetron

Intervention Type DRUG

ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia

Interventions

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aprepitant

aprepitant 80 mg is given to all patients before surgery

Intervention Type DRUG

palonosetron

palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia

Intervention Type DRUG

Ramosetron

ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non smoking, female patients, scheduled for laparoscopic cholecystectomy

Exclusion Criteria

* Patients with gastrointestinal disorder,
* Patients with allergies to any study medication,
* Patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Younghoon Jeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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KNUH 2014-05-016

Identifier Type: -

Identifier Source: org_study_id

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