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A study to assess benefit of propranolol in severely head injured patients when on ventilator.

Use of beta blocker in severely head injured patients receiving mechanical ventilation in trauma intensive care: A prospective randomized double-blind study - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060792
Enrollment
56
Registered
2023-12-26
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: S060- Concussion Health Condition 2: S062- Diffuse traumatic brain injury Health Condition 3: S064- Epidural hemorrhage Health Condition 4: S063- Focal traumatic brain injury Health Condition 5: S068- Other specified intracranial injuries Health Condition 6: S061- Traumatic cerebral edema Health Condition 7: S066- Traumatic subarachnoid hemorrhage Health Condition 8: S065- Traumatic subdural hemorrhage Health Condition 9: S069- Unspecified intracranial injury

Interventions

Intervention1: Group 1: 20 mg of oral propranolol every 12 hourly for 3 days following ICU admission Control Intervention1: Group 2: placebo every 12 hourly for 3 days following ICU admission

Sponsors

PGIMER, Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ? Adult patients 18-65 years of age, with severe TBI (Glasgow Coma Scale ? Admitted to Trauma Intensive Care Unit (ICU) for mechanical ventilatory support and conservative management

Exclusion criteria

Exclusion criteria: Age 65years

Design outcomes

Primary

MeasureTime frame
Transcranial doppler assessed cerebral perfusion pressure changesTimepoint: Day 1 to 3

Secondary

MeasureTime frame
1. Changes in cerebral hemodynamics evaluated using Transcranial Doppler at pre-specified time intervals 2. Serum catecholamine levels at baseline and 72 hours of admission to ICU 3. Bedside Optic Nerve Sheath Diameter at pre-specified time intervals 4. Length of ICU and hospital stay 5. Incidence of neurological worsening 6. 30-day mortality outcome 7. Functional status at 3 months following discharge using the Glasgow Outcome Scale-Extended (GOS-E)Timepoint: Day 1, 2, 3, 30 and 3 months

Countries

India

Contacts

Public ContactANKITA GOYAL

Post Graduate Institute of Medical Sciences and Research, Chandigarh

nidhi.bhatia75@gmail.com9914207483

Outcome results

None listed

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