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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550795
• Other study ID #: Breast PONV
• Secondary ID: GCIRB2014
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2020
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Dexmedetomidine
administration of dexmedetomidine only
• Dexmedetomidine and dexamethasone
administration of dexmedetomidine and dexamethasone
• Control
administration of normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative Vomiting (Number of Participants With Vomiting)	frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively	Changes from baseline in postoperative nausea at 30 min
Secondary	Rhodes Index Score	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