Effects of a Single Dose Dexmedetomidine on Postoperative Nausea and Vomiting (PONV) and Quality of Recovery 40 (QoR 40) in Breast Cancer Surgery
20 Years
60 Years
Female
Breast Cancer
Trial Information
Effects of a Single Dose Dexmedetomidine on Postoperative Nausea and Vomiting (PONV) and Quality of Recovery 40 (QoR 40) in Breast Cancer Surgery
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.
Inclusion Criteria:
- ASA I, II
- aged 20-60 years
- Undergoing breast cancer surgery
Exclusion Criteria:
- CAOD
- Bradycardia
- QT prolongation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Quality of Recovery 40 (QoR-40)
Outcome Description:
quality of recovery was determined by QOR-40 questionnaire. (all same as Dexmedetomidine group and Placebo group)
Outcome Time Frame:
24 postoperative hours
Safety Issue:
Yes
Authority:
Korea: Food and Drug Administration
Study ID:
4-2011-0415
NCT ID:
NCT01548209
Start Date:
September 2011
Completion Date:
July 2012
Related Keywords:
- Breast Cancer
- Breast Neoplasms
- Postoperative Nausea and Vomiting
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