Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer

August 11, 2020 updated by: Youn Yi Jo, Gachon University Gil Medical Center

Effects of Single Dose Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer

Previous reports demonstrated that dexmedetomidine could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous reports demonstrated that dexmedetomidine, a alpha 2 selective agonist could reduce the incidence of postoperative nausea and vomiting (PONV). Dexamethason also had been commonly used for ajuvant drugs for preventing and reducing PONV. So investigator want to study about the effect of dexmedetomidine only or combined with dexamethasone for preventing PONV.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.

Exclusion Criteria:

  • uncontrolled cardiovascular disease
  • history of chronic pain
  • smoker
  • previous history of steroid administraion
  • neoajuvant chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
administration of 0.9% normal saline 10ml
Drug: Control
administration of normal saline
Other Names:
  • OO
Active Comparator: Dexmedetomidine
administration of 0.5ug/kg of dexmedetomidine (5ml)
Drug: Dexmedetomidine
administration of dexmedetomidine only
Other Names:
  • DO
Active Comparator: Dexmedetomidine and dexamethasone
administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Drug: Dexmedetomidine and dexamethasone
administration of dexmedetomidine and dexamethasone
Other Names:
  • DD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Nausea (Numeric Rating Scale for Nausea)
Time Frame: Changes from baseline in postoperative nausea at 30 min
Numeric rating scale for postoperative nausea (scores on a scale) (0-no symptoms; 10-worst symptoms imaginable). Ramosetron 0.3 mg was administered to patients with nausea >5 points on the numeric rating scale
Changes from baseline in postoperative nausea at 30 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Vomiting (Number of Participants With Vomiting)
Time Frame: Changes from baseline in postoperative nausea at 30 min
frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively
Changes from baseline in postoperative nausea at 30 min
Rhodes Index Score
Time Frame: assessed at 6 and 24 hour after operative end
Rhodes Index of nausea, vomiting, and retching at 6 to 24 hours after surgery (ask 8 question about discomfort due to PONV and each questions are consist of 0~4 score) (minimal PONV 0 to maximal PONV 32) lower values represent a bettwer outcome
assessed at 6 and 24 hour after operative end

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 30, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Breast PONV
  • GCIRB2014 (Registry Identifier: GCIRB2014-154)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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