Preoperative anxiety and postoperative delirium
Conditions
Interventions
TJ-54 TSUMURA Yokukansan Extract Granules for Ethical Use Oral administration of Yokukansan (7.5g/day t.i.d. before meals) for at least 4 days before operation.
Placebo granules. Oral administration
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histological cancer diagnosis or clinical necessity undertaking neoplasm resection 2.Being scheduled to undergo highly invasive surgery. 3.Marking more than 1 point of Hospital Anxiety and Depression Scare-Anxiety (HADS-A) in registration 4.Feasibility of oral Yokukansan administration 5.Written informed consent to participate in this study
Exclusion criteria
Exclusion criteria: 1.Drug abuse history including the stimulant drug 2.Delirium diagnosis with DSM-5 in registration 3.Kampo medication within 4 weeks ahead of registration 4.Medical history of serious drug allergy 5.Grade2 Hypokalemia or worse of CTCAE v4.0 within 8 weeks ahead of registration 6.Chemotherapy and/or radiotherapy planned within 1 week after surgery 7.Participation in other clinical trials, which use other medicine, within 3 months ahead of registration 8.Being judged as inadequate by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in preoperative anxiety 2.Incidence rate of postoperative delirium | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Severity of postoperative delirium (DRS-98-R) 2.Duration of postoperative delirium 3.Preoperative Benzodiazepine dose 4.Postoperative antipsychotic dose 5.Postoperative hospitalization days 6.Adverse events/reactions | — |
Countries
Japan
Contacts
Public ContactSaho Wada
National Cancer Center Hospital Department of Psycho-Oncology
Outcome results
None listed