臨床研究等提出・公開システム

Preventive effect of ramelteon on delirium in ICU

Preventive effect of ramelteon on delirium in ICU

0

The subject was not registered.

The subject was not registered.

There were no registered patients, so there were no illnesses.

Since there were no registered patients, we were unable to obtain evaluation items and perform analysis.

There was no patient registration

April. 30, 2025

No

There are no IPD data because the trial was stopped due to 0 patient enrollment.

https://jrct.mhlw.go.jp/latest-detail/jRCTs041200112

Numaguchi Atushi

Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya city, Aichi

nummer0116@gmail.com

Numaguchi Atushi

Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya city, Aichi

+81-52-744-2659

nummer0116@gmail.com

Complete

Mar. 11, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

1) ICU patients 18 years old or more, expected to stay in ICU for over 48 hours.
2) Patients registered within 48hours of ICU admission and administrated first medication on the registration day.

1) Patients under 18 years old.
2) Allergy to ramelteon.
3) Patients with severe liver injury (T-Bil >= 10 mg/dL, or ALT >= 750 IU/L).
4) Patients receiving fluvoxamine maleate.
5) Patients already receiving ramelteon therapy before admission.
6) Patients expected to leave ICU within 48 hours of admission.
7) Patients expected to die within 48 hours of admission or be excluded from active treatment.
8) Pregnant or lactating women.
9) Patients expected to be difficult to evaluate delirium by CAM-ICU due to neurological problems such as post-cardiac arreest, head trauma, stroke, or other illness.
10) Absence of written informed consent.

Both

Patients who need ICU management.

Arm ramelteon: Over-encapsulated ramelteon (8 mg) given either orally or via nasogastric tube at 20:00 hours for 14 consecutive nights or until ICU discharge, whichever occurs first.
Arm placebo: Over-encapsulated maltitol given either orally or via nasogastric tube at 20:00 hours for 14 consecutive nights or until ICU discharge, whichever occurs first.

intensive care

Ramelteon

D007362

D000284

Occurrence of ICU-delirium

Length of delirium, severity and need for treatment of delirium, length and quality of sleep, length of ICU and hospital stay, 28- and in-hospital mortality, ventilator free days (number of days without ventilator use from day 1 to day 28), dose of sedative drugs.

+81-52-744-2479

Mar. 02, 2021

none