Effect of Early Sympathetic activity suppression on neuroinflammation, cerebral metabolites, and outcome in head injury patients

Effect of pharmacological sympathetic activity suppression on neuroinflammation, cerebral metabolites, and outcome in head injury patients- a randomized placebo controlled study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084567

Enrollment

Registered

2025-04-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: S069- Unspecified intracranial injury

Interventions

Intervention1: Dexmedetomidine group (Group DEX): Loading dose: 0.5mcg/kg IV over 10 minutes Maintenance dose: 0.4mcg/kg/hr IV infusion to achieve a target heart rate (HR) of 60-70 beats/minute. Dose

Eligibility

Inclusion criteria

Inclusion criteria: Patients of 18-70 years of the age group of either gender are admitted to the NICU within 48 hours following moderate to severe TBI with post resuscitation GCS of less than 12

Exclusion criteria

Exclusion criteria: 1.Pregnant patients 2.Patients with poor prognosis Glasgow coma score (GCS) of 3 on admission 3.Polytrauma with life threatening injuries 4.Any known hypersensitivity to dexmedetomidine or esmolol 5.History of Bronchial asthma 6.Presence of cardiogenic shock 7.Conduction block in ECG or any known history of arrhythmia 8.Patients on prior beta-blocker therapy 9.Unable to obtain informed consent from the next of kin of the patients

Design outcomes

Primary

Measure	Time frame
To measure the levels of interleukins-1L1, 6, 10 in brain interstitial fluid by cerebral microdialysis in moderate to severe traumatic brain injury patients receiving infusions of dexmedetomidine vs esmolol.Timepoint: Twice daily till the ICP is less than 20 mmHg for 48 hours or a maximum of 5 days	—

Secondary

Measure	Time frame
To measure the levels of lactate, pyruvate, glucose, glutamate in brain interstitial fluid by CMD in moderate to severe traumatic brain injury patients receiving infusions of dexmedetomidine vs esmololTimepoint: Twice daily till the ICP is less than 20 mmHg for 48 hours or a maximum of 5 days from the day of ICU admission;To compare the long-term (90 days and 180 days) neurological outcomes measured by Glasgow outcome scale in patients receiving infusions of dexmedetomidine vs esmololTimepoint: 90 and 180 days after TBI	—

Measure

Time frame

To measure the levels of lactate, pyruvate, glucose, glutamate in brain interstitial fluid by CMD in moderate to severe traumatic brain injury patients receiving infusions of dexmedetomidine vs esmololTimepoint: Twice daily till the ICP is less than 20 mmHg for 48 hours or a maximum of 5 days from the day of ICU admission;To compare the long-term (90 days and 180 days) neurological outcomes measured by Glasgow outcome scale in patients receiving infusions of dexmedetomidine vs esmololTimepoint: 90 and 180 days after TBI

—

Countries

India

Contacts

Public ContactDr Rajeeb Kumar Mishra

National Institute of Mental health and neurosciences

litu86@gmail.com9968961339

Outcome results

None listed

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