Effects of a Dexmedetomidine on Quality of Recovery 40 and Postoperative Nausea and Vomiting in Breast Cancer Surgery

NCT ID: NCT01548209

Last Updated: 2015-02-02

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

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-08-31

Brief Summary

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Postoperative nausea and vomiting (PONV) is common following beast surgery. Dexmedetomidine was reported to a reduced PONV due to opioid-sparing effect. It is not clear if dexmedetomidine itself is useful on reducing PONV. The hypothesis of present study: intraoperative application of single dose dexmedetomidine (0.5 mcg/kg) is is effective than placebo for reducing of PONV and improve postoperative quality of recovery score within 48 postoperative hours.

Detailed Description

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This study was approved by the Institutional Review Board of Severance Hospital, Yonsei University Health System. After written informed consent was obtained from all patients, aged 20-75 years with ASA physical status class I-II who were scheduled breast cancer surgery under general anaesthesia were enrolled in this study All the patients were randomly assigned to receive dexmedetomidine or placebo during surgery. The primary outcome was quality of recovery determined by QOR-40 in the first 24h after surgery.The secondary outcome measure was PONV assessed by visual analogue scale every 6 hours within 48 postoperative hours.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group D

A single dose dexmedetomidine 0.5 mcg/kg iv. 30 min before end of the surgery

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

A single dose dexmedetomidine 0.5 mcg/kg IV. 30 min before end of the surgery

Group P

Placebo 0.5 mcg/kg iv. 30 min before end of the surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 0.5 mcg/kg iv. 30 min before end of the surgery

Interventions

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Dexmedetomidine

A single dose dexmedetomidine 0.5 mcg/kg IV. 30 min before end of the surgery

Intervention Type DRUG

Placebo

Placebo 0.5 mcg/kg iv. 30 min before end of the surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I, II
* aged 20-70 years
* Undergoing breast cancer surgery

Exclusion Criteria

* CAOD
* Bradycardia
* QT prolongation
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 250 Seungsan-no, Seodaemun-gu

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2011-0415

Identifier Type: -

Identifier Source: org_study_id

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