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

Gachon University Gil Medical Center

Status: Completed

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Control; Drug: Dexmedetomidine and dexamethasone; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02550795

GCIRB2014 (Registry Identifier)

Breast PONV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

administration of 0.9% normal saline 10ml

Treatment:

Drug: Control

Dexmedetomidine

Active Comparator group

Description:

administration of 0.5ug/kg of dexmedetomidine (5ml)

Treatment:

Drug: Dexmedetomidine

Dexmedetomidine and dexamethasone

Active Comparator group

Description:

administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)

Treatment:

Drug: Dexmedetomidine and dexamethasone