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

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Control; Drug: Dexmedetomidine and dexamethasone; Drug: Dexmedetomidine

• Registration Number: NCT02550795
• Lead Sponsor: Gachon University Gil Medical Center

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 Timeline

• Study First Submitted: 2015-08-30
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Results First Submitted: 2019-02-14
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-11
• Last Update Submitted: 2020-08-11
• Results First Posted: 2020-08-24
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	administration of 0.9% normal saline 10ml
Dexmedetomidine and dexamethasone	Dexmedetomidine and dexamethasone	administration of 0.5 ug/kg of dexmedetomidine and dexamethasone 5mg (total 5ml)
Dexmedetomidine	Dexmedetomidine	administration of 0.5ug/kg of dexmedetomidine (5ml)

Primary Outcome Measures

Name	Time	Method
Postoperative Nausea (Numeric Rating Scale for Nausea)	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 Outcome Measures

Name	Time	Method
Rhodes Index Score	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
Postoperative Vomiting (Number of Participants With Vomiting)	Changes from baseline in postoperative nausea at 30 min	frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively