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Completed

NCT Number: NCT02550795

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

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

administration of dexmedetomidine only

Other names: DO

Dexmedetomidine and dexamethasone

Drug

administration of dexmedetomidine and dexamethasone

Other names: DD

Control

Drug

administration of normal saline

Other names: OO

Primary outcomes

  1. 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

  1. Postoperative Vomiting (Number of Participants With Vomiting)

    Time frame: Changes from baseline in postoperative nausea at 30 min

    frequencies of vomiting (number of participants with vomiting) 24 hour post-operatively

  2. Rhodes Index Score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2015
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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