NCT01548209

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

10 months

First QC Date

February 27, 2012

Last Update Submit

January 30, 2015

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery 40 (QoR-40)

    quality of recovery was determined by QOR-40 questionnaire. (all same as Dexmedetomidine group and Placebo group)

    24 postoperative hours

Secondary Outcomes (1)

  • Change from preoperative baseline in PONV within 48 postoperative hours

    every 6 hours within 48 postoperative hours

Study Arms (2)

Group D

EXPERIMENTAL

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

Drug: Dexmedetomidine

Group P

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DexmedetomidineDRUG

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

Group D
PlaceboDRUG

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

Group P

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • CAOD
  • Bradycardia
  • QT prolongation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 8, 2012

Study Start

September 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations

KR(1)