Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer

NCT ID: NCT02550795

Last Updated: 2020-08-24

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-12-31

Brief Summary

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Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

Detailed Description

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Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

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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Control

administration of 0.9% normal saline 10ml

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DRUG

administration of normal saline

Dexmedetomidine

administration of 0.5ug/kg of dexmedetomidine (5ml)

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

administration of dexmedetomidine only

Dexmedetomidine and dexamethasone

administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)

Group Type ACTIVE_COMPARATOR

Dexmedetomidine and dexamethasone

Intervention Type DRUG

administration of dexmedetomidine and dexamethasone

Interventions

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Dexmedetomidine

administration of dexmedetomidine only

Intervention Type DRUG

Dexmedetomidine and dexamethasone

administration of dexmedetomidine and dexamethasone

Intervention Type DRUG

Control

administration of normal saline

Intervention Type DRUG

Other Intervention Names

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DO DD OO

Eligibility Criteria

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Inclusion Criteria

* ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.

Exclusion Criteria

* uncontrolled cardiovascular disease
* history of chronic pain
* smoker
* previous history of steroid administraion
* neoajuvant chemotherapy
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Youn Yi Jo

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GCIRB2014

Identifier Type: REGISTRY

Identifier Source: secondary_id

Breast PONV

Identifier Type: -

Identifier Source: org_study_id

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