| CTRI Number |
CTRI/2025/11/097008 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see if adding an extra medicine named dexmedetomidine to a routine medicine named lorazepam helps to calm and treat unwell people in intensive care unit who are anxious
or sick because they stopped drinking alcohol.
|
|
Scientific Title of Study
|
Effect of dexmedetomidine as an adjunct to lorazepam for
alcohol withdrawal syndrome in icu: a prospective randomized controlled double blinded study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nimisha George |
| Designation |
Senior Resident |
| Affiliation |
Jubilee mission medical college and research institute |
| Address |
Department of critical care medicine
Jubilee mission medical college and research institute
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
9423803428 |
| Fax |
|
| Email |
nimisha19191@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Cherish Paul |
| Designation |
Professor |
| Affiliation |
Jubilee mission medical college and research institute |
| Address |
Department of critical care medicine
Jubilee mission medical college and research institute
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
8281295677 |
| Fax |
|
| Email |
drcherish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nimisha George |
| Designation |
Senior Resident |
| Affiliation |
Jubilee mission medical college and research institute |
| Address |
Department of critical care medicine
Jubilee mission medical college and research institute
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
9423803428 |
| Fax |
|
| Email |
nimisha19191@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jubilee mission medical college and research institute
Thrissur,Kerala,India
680005 |
|
|
Primary Sponsor
|
| Name |
Nimisha George |
| Address |
Department of critical care medicine
Jubilee mission medical college and research institute
Thrissur |
| Type of Sponsor |
Other [self] |
|
|
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 Nimisha George |
Jubilee Mission Medical college and Research Institute |
Advanced Critical Care Unit
Department of critical care medicine
Thrissur
KERALA |
9423803428
nimisha19191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee at Jubilee mission medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F101||Alcohol abuse, (2) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine + Lorazepam |
Intravenous infusion of Dexmedetomidine 0.2mcg/kg to 0.7mcg/kg for 2 days and Oral Lorazepam fixed tapering dose of 2mg, 6th hourly for 2 days, 2mg 8th hourly for 1 day, 2mg 12th hourly for 1 day,2mg once daily for one day and 1mg once daily for one day, total duration of therapy for 6 days |
| Comparator Agent |
Lorazepam |
Oral Lorazepam fixed tapering dose of 2mg, 6th hourly for 2 days, 2mg 8th hourly for 1 day, 2mg 12th hourly for 1 day,2mg once daily for one day and 1mg once daily for one day, total duration of therapy for 6 days along with intravenous infusion of saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients admitted in ICU with medical or surgical illness with features of alcohol withdrawal syndrome or alcohol withdrawal delirium
as per DSM V definition at the time of ICU
admission |
|
| ExclusionCriteria |
| Details |
Active status epilepticus,Pregnancy or lactation,Known allergy or adverse response to any of the study medications,Severe hepatic impairment (Child Pugh C ),Serious central nervous system pathology (acute stroke, uncontrolled seizures, severe
dementia),Heart rate less than 50 per min,Second- or third degree heart block,Systolic blood pressure less than 90 mm Hg despite continuous infusions of more than
o.8microgram per hour infusion of noradrenaline before allocation to study group,Previous randomization into this study,those who are not expected to stay in ICU for less than 48 hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing delirium free days in intervention group and control group. |
Delirium free days - 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparing mMINDS score,
comparing length of ICU stay ( in days),comparing ventilator free days,comparing the use of additional sedatives to achieve RASS 0 to -2 |
mMINDS at the time of admission,after 48hours.
Length of ICU stay till discharge from ICU
Ventillator free days till discharge from ICU
Use of additional sedatives in first 7 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="2"
Months="0"
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 randomized , double blind , parallel group , single center trial comparing the effectiveness of lorazepam and dexmedetomidine infusion versus lorazepam alone in patients with alcohol withdrawal symptoms in intensive care unit and this study will be conducted in critical care Department.The primary outcome will be delirium free days in first 7 days of admission in each group and secondary outcome will be comparison between two groups with respect to the number of patients achieving a significant reduction in mMINDS after 48 hours ,length of ICU stay (in days),ventilator free days, incidences of rescue sedation in each group.
|