Skip to content

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.

Effect of dexmedetomidine as an adjunct to lorazepam for alcohol withdrawal syndrome in icu: a prospective randomized controlled double blinded study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097008
Enrollment
50
Registered
2025-11-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F101- Alcohol abuse Health Condition 2: F102- Alcohol dependence

Interventions

Intervention1: 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 hou

Sponsors

Nimisha George
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Comparing delirium free days in intervention group and control group.Timepoint: Delirium free days - 7 days

Secondary

MeasureTime frame
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 -2Timepoint: 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

Countries

India

Contacts

Public ContactNimisha George

Jubilee mission medical college and research institute

drcherish@gmail.com8281295677

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026