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

Effects of a Single Dose Dexmedetomidine on Postoperative Nausea and Vomiting (PONV) and Quality of Recovery 40 (QoR 40) in Breast Cancer Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01548209

Enrollment

Registered

2012-03-08

Start date

2011-09-30

Completion date

2012-08-31

Last updated

2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Detailed description

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.

Interventions

DRUGDexmedetomidine

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* CAOD * Bradycardia * QT prolongation

Design outcomes

Primary

Measure	Time frame	Description
Quality of Recovery 40 (QoR-40)	24 postoperative hours	quality of recovery was determined by QOR-40 questionnaire. (all same as Dexmedetomidine group and Placebo group)

Secondary

Measure	Time frame	Description
Change from preoperative baseline in PONV within 48 postoperative hours	every 6 hours within 48 postoperative hours	PONV was determined by visual analogue scale, number of emetic episode every 6 hours within 48 postoperative hours (all same as Dexmedetomidine group and Placebo group)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026