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

This study is currently recruiting participants.
Verified July 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01548209
First received: February 27, 2012
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Drug: Dexmedetomidine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Quality of Recovery 40 (QoR-40) [ Time Frame: 24 postoperative hours ] [ Designated as safety issue: Yes ]

    quality of recovery was determined by QOR-40 questionnaire.

    (all same as Dexmedetomidine group and Placebo group)



Secondary Outcome Measures:
  • Change from preoperative baseline in PONV within 48 postoperative hours [ Time Frame: every 6 hours within 48 postoperative hours ] [ Designated as safety issue: Yes ]

    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)



Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: July 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I, II
  • aged 20-60 years
  • Undergoing breast cancer surgery

Exclusion Criteria:

  • CAOD
  • Bradycardia
  • QT prolongation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548209

Contacts
Contact: Yong Seon Choi, MD,PhD 82-2-2227-3556 yschoi@yuhs.ac
Contact: Shin Hyung Kim, MD 82-2-2227-3556 tessar@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 250 Seungsan-no, Seodaemun-gu Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yong Seon Choi, MD, PhD     82-2-2227-3556     yschoi@yuhs.ac    
Contact: Shin Hyung Kim, MD, PhD     82-2-2227-3556     tessar@yuhs.ac    
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01548209     History of Changes
Other Study ID Numbers: 4-2011-0415
Study First Received: February 27, 2012
Last Updated: July 19, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Postoperative Nausea and Vomiting
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Postoperative Complications
Pathologic Processes
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Vomiting
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on May 21, 2013