| CTRI Number |
CTRI/2024/05/067172 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effect of two doses of tablet melatonin on occurrence of ICU delirium |
|
Scientific Title of Study
|
Comparison of the effect of two prophylactic doses of tablet melatonin on incidence of delirium in 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 Ajith Kumar P |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building,
Safdarjung Hospital Campus, Ansari Nagar west,
New Delhi
DELHI
110029
South
DELHI
110029
India |
| Phone |
9500921782 |
| Fax |
|
| Email |
P.ajithkumar1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santvana Kohli |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building,
Safdarjung Hospital Campus, Ansari Nagar west,
New Delhi
DELHI
110029
South
DELHI
110029
India |
| Phone |
7838434398 |
| Fax |
|
| Email |
dr.santvana.kohli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santvana Kohli |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building,
Safdarjung Hospital Campus, Ansari Nagar west,
New Delhi
DELHI
110029
South
DELHI
110029
India |
| Phone |
7838434398 |
| Fax |
|
| Email |
dr.santvana.kohli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital,
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building,
Safdarjung Hospital Campus, Ansari Nagar west,
New Delhi
DELHI
110029
|
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building,
Safdarjung Hospital Campus, Ansari Nagar west,
New Delhi
DELHI
110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajith Kumar P |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anesthesia and Intensive Care, ground floor, main operation theatre building,
Safdarjung Hospital Campus, Ansari Nagar west,
New Delhi
DELHI
110029
South
DELHI |
9500921782
P.ajithkumar1997@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
|
|
|
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 |
Melatonin |
Melatonin 3mg will be given orally at night time for a total of 5 days |
| Intervention |
Melatonin |
Melatonin 6mg will be given orally at night time for a total of 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Preserved oral/enteral intake within the first 48 hours of ICU admission.
2. Patients requiring an ICU stay of at least 5 days.
3. Richmond Agitation Sedation Scale (RASS) score within + 2 or - 2 on admission |
|
| ExclusionCriteria |
| Details |
1. Hemodynamically unstable patients or on vasopressor support
2. Patients on psychotropic medications or having known psychiatric illness
3. Patients with debilitating neurological diseases and low GCS less than 10 on admission
4. Pregnant patients
5. Patient with known or suspected allergy to melatonin |
|
|
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 once at 9 am and after giving the melatonin tablet at 9pm for a period of 5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare length of Intensive Care Unit stay in 2 study groups.
2. To compare the incidence of headache, dizziness and day-time sleepiness between the
two study groups. |
At the end of their hospital stay |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/05/2024 |
| 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 compare the effect of two doses of tablet melatonin on occurrence of ICU delirium , with the hypothesis that 6mg dose of melatonin causes a significantly greater reduction in the incidence of delirium as compared to the 3mg dose in patients admitted in Intensive Care Unit. Oral Melatonin 6mg and 3mg will be administered within 48 hours of ICU admission in each groups 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 at 09:00 PM for five days. |