Effects of Single Dose Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Primary Endpoint
- Postoperative Nausea (Numeric Rating Scale for Nausea)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •previous history of steroid administraion
- •neoajuvant chemotherapy
Arms & Interventions
Control
administration of 0.9% normal saline 10ml
Intervention: Control (Drug)
Dexmedetomidine
administration of 0.5ug/kg of dexmedetomidine (5ml)
Intervention: Dexmedetomidine (Drug)
Dexmedetomidine and dexamethasone
administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Intervention: Dexmedetomidine and dexamethasone (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Investigators
Youn Yi Jo
Assistant professor
Gachon University Gil Medical Center