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

February 27, 2012
July 19, 2012
September 2011
January 2012   (final data collection date for primary outcome measure)
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)

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)

Complete list of historical versions of study NCT01548209 on ClinicalTrials.gov Archive Site
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)

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)

Not Provided
Not Provided
 
Effects of a Dexmedetomidine on Quality of Recovery 40 and Postoperative Nausea and Vomiting in Breast Cancer Surgery
Effects of a Single Dose Dexmedetomidine on Postoperative Nausea and Vomiting (PONV) and Quality of Recovery 40 (QoR 40) in Breast Cancer Surgery

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Breast Cancer
  • Drug: Dexmedetomidine
    A single dose dexmedetomidine 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
  • Experimental: Group D
    A single dose dexmedetomidine 0.5 mcg/kg iv. 30 min before end of the surgery
    Intervention: Drug: Dexmedetomidine
  • Placebo Comparator: Group P
    Placebo 0.5 mcg/kg iv. 30 min before end of the surgery
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • CAOD
  • Bradycardia
  • QT prolongation
Female
20 Years to 60 Years
No
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
Korea, Republic of
 
NCT01548209
4-2011-0415
Yes
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP