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Role of drug dexmedetomidine by inhalation to prevent delirium

Effectiveness of nocturnal dexmedetomidine nebulization for the prevention of delirium in ICU patient: A randomized, placebo-controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021668
Enrollment
100
Registered
2019-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: F439- Reaction to severe stress, unspecified Health Condition 2: F439- Reaction to severe stress, unspecified

Interventions

Intervention1: Dexmedetomidine nebulization: Group I Patient will be nebulized at night with dose of dexmedetomidine 1µg/kg diluted upto 4ml by normal saline Route of administration-inhalational Fr

Sponsors

AIIMS Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 to 60 2. Admitted to the ICU of more than 48 hours 3. Non-intubated patient

Exclusion criteria

Exclusion criteria: 1. Elderly patients age >60 2. Preexisting cognitive impairments 3. Allergic to dexmedetomidine 4. Inability to obtain informed consent 5. Hearing impaired, legally blind 6. admitted with alcohol intoxication, prisoners, Psychiatric disorder 7. Haemodynamic instability, bradyarrhythmias (Heart rate 8. Presence of delirium [Intensive Care Delirium Screening Checklist- (ICDSC >4)], RASS: Richmond Agitation Sedation Scale (RASS) 9. History of epilepsy, Acute alcohol withdrawal requiring benzodiazepine administration, history of hepatic encephalopathy, irreversible brain disease consistent with severe dementia, admitted with primary neurologic condition or injury (e.g., intracranial hemorrhage) 10. Current treatment with dexmedetomidine or clonidine 11. Unstable intubated patients, terminally ill, patients undergoing major surgery 12. Pregnancy

Design outcomes

Primary

MeasureTime frame
Proportion of patients who remained free of delirium during their critical illness (i.e., ICU admission).Timepoint: Daily at 7am and 7pm for initial 5 days

Secondary

MeasureTime frame
Sedation score (RASS) and midazolam consumptionTimepoint: Sedation score from 10pm to 7am for initial 5 days

Countries

India

Contacts

Public ContactDr Neeraj Kumar

AIIMS Patna

neeraj.jlnmc@gmail.com8210104972

Outcome results

None listed

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