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CTRI Number  CTRI/2023/08/056002 [Registered on: 02/08/2023] Trial Registered Prospectively
Last Modified On: 28/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Other 
Public Title of Study   Assessing the role of oral melatonin agonist ramelteon in prevention of ICU delirium 
Scientific Title of Study   Evaluation of effect of oral melatonin agonist ramelteon for prevention of delirium in adult patients admitted in intensive care unit 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kashish Chawla 
Designation  Post Graduate Resident 
Affiliation  Vardhman Mahavir Medical College And Safdarjung Hospital 
Address  Department of Anaesthesia and Critical Care
Ansari Nagar East,Near to AIIMS Metro Station New Delhi 110029
South
DELHI
110029
India 
Phone  7015218988  
Fax    
Email  kashishchawla000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajpal Singh 
Designation  Consultant and Professor 
Affiliation  Vardhman Mahavir Medical College And Safdarjung Hospital 
Address  Department of Anaesthesia and Critical Care Vardhman Mahavir Medical College and Safdarjung hospital
Ansari Nagar East Near Near to AIIMS Metro Station New Delhi 110029
South
DELHI
110029
India 
Phone  9911858311  
Fax    
Email  doctorrajpal04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kashish Chawla 
Designation  Post Graduate Resident 
Affiliation  Vardhman Mahavir Medical College And Safdarjung Hospital 
Address  Department of Anaesthesia and Critical Care VMMC AND Safadarjung hospital
Ansari Nagar East,Near to AIIMS Metro Station New Delhi 110029
South
DELHI
110029
India 
Phone  7015218988  
Fax    
Email  kashishchawla000@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College And Safdarjung hospital Ansari Nagar East,Near to AIIMS Metro Station New Delhi 110029 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College And Safdarjung hospital 
Address  Near AIIMS Hospital, Ansari Nagar New Delhi - 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kashish Chawla  Vardhman Mahavir Medical College and Safdarjung Hospital  Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi 110029
South
DELHI 		 7015218988

kashishchawla000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Vardhman Mahavir Medical College and Safdarjung Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F05||Delirium due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lactose powder  Lactose powder as placebo will be given at night for 5 days along with continuous non-pharmacological measures to reduce delirium. 
Intervention  Ramelteon   Melatonin Agonist Ramelteon 8mg will be given orally at night time for a total of 5 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.With Preserved ORAL/Enteral intake by the Patient
2.With Richmond Agitation scale(RASS0 score within +2 or -2 during ICU stay 
 
ExclusionCriteria 
Details  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  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of delirium  Twice a day at 9 AM and 9 PM for a total period of 5 days 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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