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Clinical Trials/JPRN-jRCT1031190049
JPRN-jRCT1031190049
Recruiting
Phase 2

Prospective randomized controlled trial to investigate the effect of yokukansan on perioperative anxiety and pain

Baba Hiroshi0 sites40 target enrollmentJuly 2, 2019
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Baba Hiroshi
Enrollment
40
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 2, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Baba Hiroshi

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients who are diagnosed with breast cancer and who undergo total mastectomy and sentinel lymph node biopsy, partial mastectomy and sentinel lymph node biopsy at Niigata University Medical and Dental Hospital and Niigata Cancer Center.
  • •2\. Patients who received written and oral explanations on this study and who showed consent to participate in writing.

Exclusion Criteria

  • •1\. If the subject's consent cannot be obtained.
  • •2\. The patients whose physical status classification of American Society of Anesthesiology are (ASA \- PS) 4 or more.
  • •3\. The patients whose BMI (Body Mass Index) are more than 30
  • •4\. Patients who already have pain anywhere in the body except for the original disease.
  • •5\. The patients who are allergic to the drugs used in this study.
  • •6\. The patients with hypokalemia.
  • •7\. The patients who take anxiolytics or psychotropic drug.
  • •8\. The patients already using analgesics including opioids.
  • •9\. The patients who are difficult to communicate (dementia, mental retardation, mental illness, not understanding Japanese).
  • •10\. The patients who are judged inappropriate by doctors

Outcomes

Primary Outcomes

Not specified

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