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

Yonsei University97 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Breast Cancer

Interventions

DexmedetomidineDRUG

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Seoul, South Korea

Outcomes

Primary Outcomes

Quality of Recovery 40 (QoR-40)

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

Time frame: 24 postoperative hours

Secondary Outcomes

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)

Time frame: every 6 hours within 48 postoperative hours

Data from ClinicalTrials.gov

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