Assessing the role of oral melatonin agonist ramelteon in prevention of ICU delirium

Phase 3

Not yet recruiting

• Conditions: Delirium due to known physiological condition,

• Registration Number: CTRI/2023/08/056002
• Lead Sponsor: Vardhman Mahavir Medical College And Safdarjung hospital

Brief Summary

This study is a prospective, interventional study to evaluate the effect of oral melatonin agonist ramelteon for prevention of delirium in adult patients admitted in Intensive care unit, with the hypothesis that administration of oral melatonin agonist ramelteon therapy reduces the incidence of delirium in adult patients admitted in intensive care unit . Oral Melatonin Agonist Ramelteon Will be Administered within 48 hours of ICU admission and GCS, RASS and CAM-ICU Scores will be performed by an ICU Doctor initially ,Baseline- on the day of Admission and Later Twice A Day, Once At The Start of the Day at 09:00 AM and after giving melatonin agonist Ramelteon at 09:00 PM for five days.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.With Preserved ORAL/Enteral intake by the Patient 2.With Richmond Agitation scale(RASS0 score within +2 or -2 during ICU stay.

Exclusion Criteria

• 1.Hemodynamically Unstable or Inotropic Support Patients 2.Patient on Psychotropic Drugs or Known psychiatric illness 3.Patient with debilitating Neurological diseases and Low GCS<10 4.
• Pregnant Patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of delirium	Twice a day at 9 AM and 9 PM for a total period of 5 days

Secondary Outcome Measures

Name	Time	Method
To Compare duration of ICU stay & mechanical ventilation in patients on Ramelteon versus who has not been administered Ramelteon	At the end of their Hospital Stay

Trial Locations

Locations (1)

Vardhman Mahavir Medical College and Safdarjung Hospital; 🇮🇳 South, DELHI, India

Vardhman Mahavir Medical College and Safdarjung Hospital

🇮🇳South, DELHI, India

Dr Kashish Chawla

Principal investigator

7015218988

kashishchawla000@gmail.com