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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548209
• Other study ID #: 4-2011-0415
• Status: Completed
• Phase: N/A
• First received: February 27, 2012
• Last updated: January 30, 2015
• Start date: September 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA I, II

• aged 20-70 years

• Undergoing breast cancer surgery

Exclusion Criteria:

• CAOD

• Bradycardia

• QT prolongation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Postoperative Nausea and Vomiting

Intervention

Drug:
• Dexmedetomidine
A single dose dexmedetomidine 0.5 mcg/kg IV. 30 min before end of the surgery
• Placebo
Placebo 0.5 mcg/kg iv. 30 min before end of the surgery

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 250 Seungsan-no, Seodaemun-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Recovery 40 (QoR-40)	quality of recovery was determined by QOR-40 questionnaire.; (all same as Dexmedetomidine group and Placebo group)	24 postoperative hours	Yes
Secondary	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)	every 6 hours within 48 postoperative hours	Yes