ramelteon delirium prevention trial

Phase 3

Recruiting

• Conditions: Delirium; Delirium, postoperative delirium, malignant tumor

• Registration Number: JPRN-jRCTs031210673
• Lead Sponsor: Matsuoka Hiromichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 766

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified