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

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ClinicalTrials.gov Identifier: NCT01548209
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : February 2, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Breast Cancer Drug: Dexmedetomidine Drug: Placebo

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Study Start Date : September 2011
Primary Completion Date : July 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group D
A single dose dexmedetomidine 0.5 mcg/kg iv. 30 min before end of the surgery
Drug: Dexmedetomidine
A single dose dexmedetomidine 0.5 mcg/kg IV. 30 min before end of the surgery
Placebo Comparator: Group P
Placebo 0.5 mcg/kg iv. 30 min before end of the surgery
Drug: Placebo
Placebo 0.5 mcg/kg iv. 30 min before end of the surgery

Primary Outcome Measures :
  1. Quality of Recovery 40 (QoR-40) [ Time Frame: 24 postoperative hours ]

    quality of recovery was determined by QOR-40 questionnaire.

    (all same as Dexmedetomidine group and Placebo group)

Secondary Outcome Measures :
  1. Change from preoperative baseline in PONV within 48 postoperative hours [ Time Frame: 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)

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • CAOD
  • Bradycardia
  • QT prolongation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548209

Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 250 Seungsan-no, Seodaemun-gu
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01548209     History of Changes
Other Study ID Numbers: 4-2011-0415
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Breast Neoplasms
Postoperative Nausea and Vomiting
Neoplasms by Site
Breast Diseases
Skin Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action