Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
Effects of Single Dose Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
2 other identifiers
interventional
150
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
August 24, 2020
CompletedAugust 24, 2020
August 1, 2020
11 months
August 30, 2015
February 14, 2019
August 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative Nausea (Numeric Rating Scale for Nausea)
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 Outcomes (2)
Postoperative Vomiting (Number of Participants With Vomiting)
Changes from baseline in postoperative nausea at 30 min
Rhodes Index Score
assessed at 6 and 24 hour after operative end
Study Arms (3)
Control
PLACEBO COMPARATORadministration of 0.9% normal saline 10ml
Dexmedetomidine
ACTIVE COMPARATORadministration of 0.5ug/kg of dexmedetomidine (5ml)
Dexmedetomidine and dexamethasone
ACTIVE COMPARATORadministration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Interventions
administration of dexmedetomidine and dexamethasone
Eligibility Criteria
You may qualify if:
- ASA Physical status I or II female scheduled for breast conserving surgery of modified radical mastectomy.
You may not qualify if:
- uncontrolled cardiovascular disease
- history of chronic pain
- smoker
- previous history of steroid administraion
- neoajuvant chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Youn Yi Jo
- Organization
- Gil hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
August 30, 2015
First Posted
September 16, 2015
Study Start
September 1, 2015
Primary Completion
August 1, 2016
Study Completion
December 1, 2016
Last Updated
August 24, 2020
Results First Posted
August 24, 2020
Record last verified: 2020-08