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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I, II aged 20-70 years Undergoing breast cancer surgery Exclusion Criteria: CAOD Bradycardia QT prolongation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group D<br>A single dose dexmedetomidine 0.5 mcg/kg iv. 30 min before end of the surgery | Drug: Dexmedetomidine<br>* A single dose dexmedetomidine 0.5 mcg/kg IV. 30 min before end of the surgery<br>|
| Placebo Comparator: Group P<br>Placebo 0.5 mcg/kg iv. 30 min before end of the surgery | Drug: Placebo<br>* Placebo 0.5 mcg/kg iv. 30 min before end of the surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from preoperative baseline in PONV 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) | every 6 hours within 48 postoperative hours |