Delirium Delirium, postoperative delirium, malignant tumor
Conditions
Interventions
Ramelteon 8mg/tablet or Placebo 1 capsule per night orally or via nasogastric tube
Cointervention: multicomponent intervention to prevent delirium defined as below
Address cognitive impairment and/or
ramelteon
ramelteon, multicomponent intervention
Sponsors
Matsuoka Hiromichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed and/or clinically suspected malignant tumor 2) Aged 65 or older at enrollment 3) Undergoing surgery under general anesthesia and postoperative hospitalization for 5 days or over 4) Preoperative ability to take medication orally or via nasogastric tube and postoperative plan to take medication orally or via nausal gastric tube from postoperative day 2 or earlier. 5) Written informed consent from patient or written informed consent from witness, who is not working in the present study, with patient's oral consent.
Exclusion criteria
Exclusion criteria: 1) Diagnosed as delirium with DSM-5 at enrollment 2) Allergy to ramelteon 3) Sevea liver dysfunction according to criteria of total bil > 2.25 mg/dL, AST > 90 U/L, ALT > 126 U/L for male, or ALT > 69 U/L for female 4) History of participation to clinical trials within 4 weeks including a day of enrollment except for the completed protocol treatment and in the observation period 5) History of medication of ramelteon or flurvoxamine within 2 weeks including a day of enrollment 6) History of medication of suvorexant or lemborexant 2 weeks including a day of enrollment 7) History of epilepsy, Parkinson's dosease, or dementia with lewy bodies 8) Lactose intolerance 9) Planned surgical procesure including central nervous system or intracranial region. 10) History of drug or alcohol use disorder or daily alcohol intake over 60g or alcohol-related disease within 5 years including a day of enrollment 11) History of participation to the present study 12) Comorbidity of moderate to severe dementia according to MMSE-J < 21 13) Severe visual or auditory handicap, or illiteracy 14) ECOG PS 4 at enrolment 15) Judgement as inadequate by principal investigator or other investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of delirium diagnosis by psycho-oncologist with DSM-5 within 5 days after surgery among patients aged 75 years or older | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of delirium diagnosis by psycho-oncologist with DSM-5 within 5 days of surgery among patients aged 65 years or older Outcomes below among patients aged 65 years or older or aged 75 years or older, respectively 2. Proportion of delirium diagnosis by psycho-oncologist with DSM-5 within 5 days of surgery except for delirium within 2 hours after surgery 3. Proportion of delirium assessed with Nu-DESC within 5 days of surgery 4. Severity of delirium assessed with Nu-DESC and DRS-R-98 within 5 days of surgery 5. Proportion of severe delirium diagnosis by psycho-oncologist with DSM-5 and DRS-R-98 within 5 days of surgery 6. Duration (days) of delirium by DSM-5 7. Direct cost of hospitalization after surgery to discharge 8. Duration (days) of hospitalization after surgery 9. Proportion of antipsychotics use within 5 days of surgery 10. Proportion of discontinuation of benzodiazepine receptor agonists at one day before surgery 11. Proportion of falls, self-removal of any tubes including drip infusion and self-extubation, and physical restraint within 5 days of surgery 12. Serum concentration of C-reactive protein at postoperative day1 13. Proportion of postoperative complications according to CD classification grade 2 or worse within 5 days of surgery 14. Proportion of postoperative complications according to CD classification grade 2 or worse within 90 days of surgery 15. Overall survival within 30 days of surgery 16. Overall survival within 90 days of surgery 17. Recurrence-free survival within 90 days of surgery 18. Patient's satisfaction and subjective symptoms at postoperative day5 19. Proportion of discharge to care facility insted of home 20. Stratified analisis by PSQI cutoff score of 6 at enrollment for proportion of delirium diagnosis by psycho-oncologist with DSM-5 within 5 days of surgery | — |
Contacts
Public ContactRyoichi Sadahiro
National Cancer Center Japan
Outcome results
None listed