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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Placebo; Drug: Dexmedetomidine

• Registration Number: NCT01548209
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-08
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-30
• Last Update Posted: 2015-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 97

Inclusion Criteria

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

Exclusion Criteria

• CAOD
• Bradycardia
• QT prolongation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	Placebo	Placebo 0.5 mcg/kg iv. 30 min before end of the surgery
Group D	Dexmedetomidine	A single dose dexmedetomidine 0.5 mcg/kg iv. 30 min before end of the surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 250 Seungsan-no, Seodaemun-gu; 🇰🇷 Seoul, Korea, Republic of