Effect of yokukansan in the perioperative period

JRCT ID: jRCT1031190049

Registered date:02/07/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 07/11/2017
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Intervention group: Yokukansan (1 pack: 2.5g) was administered twice before surgery; before sleep on the day before surgery and 2 hour before of surgery.
Control group: No medication

Outcome(s)

• Primary Outcome: Salivary amylase value
• Secondary Outcome: Hospital anxiety and depression scale: HADS, State Trait Anxiety Inventory:STAI, Quality of Recovery:QOR, visual analog scele:VAS of pain

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 60age old
• Gender: Female

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Baba Hiroshi
• Secondary ID(s): UMIN000028998