Back to results

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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Dexmedetomidine

Placebo

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

CAOD
Bradycardia
QT prolongation

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group D

Group P

Arm Description

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

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

Outcomes

Primary Outcome Measures

Quality of Recovery 40 (QoR-40)

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

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)

Full Information

NCT ID

NCT01548209

First Posted

February 27, 2012

Last Updated

January 30, 2015

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01548209

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group D

Arm Type

Experimental

Arm Description

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

Arm Title

Group P

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Quality of Recovery 40 (QoR-40)

Description

quality of recovery was determined by QOR-40 questionnaire. (all same as Dexmedetomidine group and Placebo group)

Time Frame

24 postoperative hours

Secondary Outcome Measure Information:

Title

Change from preoperative baseline in PONV within 48 postoperative hours

Description

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)

Time Frame

every 6 hours within 48 postoperative hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA I, II aged 20-70 years Undergoing breast cancer surgery Exclusion Criteria: CAOD Bradycardia QT prolongation

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs