An interventional study of Dexmedetomidine and Placebo in Breast Cancer, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-02-02.
Sponsored by Yonsei University · Not applicable, Interventional, and Prevention
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 97 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
A single dose dexmedetomidine 0.5 mcg/kg iv. 30 min before end of the surgery
Drug: Dexmedetomidine
Placebo 0.5 mcg/kg iv. 30 min before end of the surgery
Drug: Placebo
A single dose dexmedetomidine 0.5 mcg/kg IV. 30 min before end of the surgery
Placebo 0.5 mcg/kg iv. 30 min before end of the surgery
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
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
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Yonsei University