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CTRI Number  CTRI/2021/02/031183 [Registered on: 10/02/2021] Trial Registered Prospectively
Last Modified On: 09/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluation of the role of melatonin as a potential drug for prevention of delirium in patients who have been operated and are admitted in the intensive care unit. 
Scientific Title of Study   Evaluation of role of exogenous melatonin in prevention of delirium in postoperative patients admitted in the intensive care unit 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kriti Gupta 
Designation  Post Graduate Student 
Affiliation  King George Medical University  
Address  Department of Anesthesiology King George Medical University Lucknow
King George Medical University Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India 
Phone  9986992554  
Fax    
Email  kriti24gupta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vipin Kumar Singh 
Designation  Associate Professor 
Affiliation  King George Medical University  
Address  Department of Anesthesiology King George Medical University Lucknow
King George Medical University Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India 
Phone  6387908355  
Fax    
Email  vipintheazad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kriti Gupta 
Designation  Post Graduate Student 
Affiliation  King George Medical University  
Address  Department of Anesthesiology King George Medical University Lucknow
King George Medical University Lucknow 226003
Lucknow
UTTAR PRADESH
226003
India 
Phone  9986992554  
Fax    
Email  kriti24gupta@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology King Georges Medical University Lucknow 260003 Uttar pradesh 
 
Primary Sponsor  
Name  Dr Kriti Gupta 
Address  Departmen of Anaesthesiology King Georges Medical University Lucknow 260003 Uttar pradesh 
Type of Sponsor  Other [self] 
 
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 KRITI GUPTA  KING GEORGES MEDICAL UNIVERSITY  TRAUMA VENTILLATORY UNIT, 3RD FLOOR, TRAUMA CENTRE, DEPARTMENT OF ANAESTHESIOLOGY,KING GEORGES MEDICAL UNIVERSITY, CHOWK, LUCKNOW 226003
Lucknow
UTTAR PRADESH 		 9986992554

kriti24gupta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KING GEORGE MEDICAL UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ADMINISTRATION OF ORAL MELATONIN TABLET 5MG AT 8 PM EVERYDAY FROM ADMISSION TO DISCHARGE  ADMINISTRATION OF ORAL TABLET MELATONIN 5MG AT 8PM EVERYDAY FROM ADMISSION INTO ICU TO DISCHARGE FROM ICU. 
Comparator Agent  Placebo Group  this group will be given 1gm lactose powder indistinguishable from study drug at 8pm daily through Ryle’s tube until ICU discharge/transfer. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Postoperative patients who are going to be ventilated more than 48 hours in the trauma ventilatory unit.
2. Adults (20years - 60 years) able to receive medication enterally (oral or via nasogastric tube) during first 48 hours of admission
 
 
ExclusionCriteria 
Details  – Not giving consent
– Sensitivity or history of allergic reaction to melatonin supplement,
– Pregnant
– Patients with paralytic ileus.
– Patient having expected stay or life expectancy of less than 48 hours
– Preexisting Premorbid pathologies particularly cognitive dysfunction, dementia, psychiatric disorders or sleep disorders
– Patients with history of head injury , substance abuse or withdrawal.
– Patients with Hearing impairments
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
On the day of discharge/transfer patient will be assessed using the CAM-ICU (Confusion Assessment Method) scale.

 The patients will be categorized as “Delirious” or “Not Delirious” on the basis of the results from the CAM-ICU scale and results will be analyzed.
 		 from admission into ICU to discharge from ICU 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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 
Date of First Enrollment (India)   12/02/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The relationship between the ICU environment and the development of delirium shows an altered release of melatonin and a fragmentation of biological and circadian rhythms. During critical illness, there is abnormal release of melatonin and its plasma concentration and that of its urinary metabolite are altered
The interest in melatonin as a potential therapeutic or prophylactic agent in the management of sleep disturbances and potentially delirium in the ICU derives from demonstrated low plasma concentrations and altered secretion patterns of melatonin in the critically ill (which was mainly established by measurements of the principle metabolite of 6-sulphatoxymelatonin (MT6) in the urine of subjects)
Hence this study will evaluate the role of exogenous melatonin in prevention of delirium in postoperative patients admitted in intensive care unit and measurement of outcome by occurrence of delirium as determined by confusion assessment – method (CAM) criteria and will attempt toestablish the reduction in incidence of delirium in post operative patients admitted in ICU after administration of exogenous oral melatonin.



 
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