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OpenTrials
Completed

NCT Number: NCT01548209

Effects of a Dexmedetomidine on Quality of Recovery 40 and Postoperative Nausea and Vomiting 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 250 Seungsan-no, Seodaemun-gu

Seoul, 120-752, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • CAOD
  • Bradycardia
  • QT prolongation

Treatment and study plan

Dexmedetomidine

Drug

A single dose dexmedetomidine 0.5 mcg/kg IV. 30 min before end of the surgery

Placebo

Drug

Placebo 0.5 mcg/kg iv. 30 min before end of the surgery

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Effects of a Single Dose Dexmedetomidine on Postoperative Nausea and Vomiting (PONV) and Quality of Recovery 40 (QoR 40) in Breast Cancer Surgery

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Feb 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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