Delirium Prevention Study

JRCT ID: jRCTs041220147

Registered date:01/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 28/04/2023
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Taking ramelteon of 8 mg will be started 7 days before the operation. Taking suvorexant of 15 mg will be started the day before the operation. Ramelteon and suvorexant will be then resumed from the day after operation and be continued until POD 10.

Outcome(s)

• Primary Outcome: The incidence of postoperative delirium (CAM-ICU)

Secondary Outcome

(1) Incidence of delirium based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
(2) Incidence hyperactive delirium
(3) Duration of delirium
(4) Treatment of delirium
(5) Intraoperative complications
(6) Postoperative complication
(7) Adverse events associated with ramelteon and suvorexant
(8) Postoperative hospital stay

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Histologically proven esophageal cancer
2) Planned radical esophagectomy
3) Age>=60 years old
4) PS 0 or 1
5) Oral medication able to be ingested without bowel obstruction or bleeding
6) WBC >= 3,000 /mm3
PLT >= 100,000 /mm3
AST<=100 IU/L,ALT<=100 IU/L
T-Bil<=2.0 mg/dl
Cre<= 1.5 mg/dl
7)Written informed consent

Exclude criteria

1) Dementia
2) Habitual use of psychotropic drug use
3) Uncontrolled diabetes
4) CAM-ICU not able to be performed
5) Habitual use of opioid or steroid
6) A history of hypersensitivity to ramelteon
7) Habitual use of drugs that inhibit or induce CYP3A

Related Information

• Primary Sponsor: Tsubosa Yasuhiro