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Comparing different doses of Dexmedetomidine (for neuroprotection) with respect to neurological recovery in patients with bleeding witihin Brain

Comparison between different doses of Dexmedetomidine Versus Placebo and their effects on neurological outcomes in patients with Aneurysmal Sub-arachnoid haemorrhage : A Prospective Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043119
Enrollment
75
Registered
2022-06-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: D1 - Dexmedetomidinelow low dose group: Patients will receive DEX 0.2 µg/kg/h infusion diluted to 50 ml for 24 hours Intervention2: D2 -Standard Dexmedetomidine Dose Group: Patients wi

Sponsors

Department of Anaesthesia and Intensive Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients in age group 18-65 years with good grade Aneurysmal SAH (Hunt & Hess grade-1 & 2 or WFNS grade-1 & 2), coming for Aneurysmal clipping or coiling

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, lung, liver, kidney, or metabolic diseases 2. Patients who had severe bradycardia or acute or chronic arrhythmias at presentation 3. Poor grade Aneurysmal SAH (Hunt & Hess grade-3-5 and WFNS grade 3-5) 4. Known allergy to dexmedetomidine 5. Patients with known Psychiatric disorders

Design outcomes

Primary

MeasureTime frame
To study the effects of different doses of Dexmedetomidine (0.2µg/kg & 0.5µg/kg) vs placebo on neurological outcome of Aneurysmal SAH patients at discharge, defined as a Modified Rankin Scale (mRS) score of 0â??2.Timepoint: At discharge

Secondary

MeasureTime frame
Comparison of S100β protein and NSE (Neuron Specific Enolase) levels at Pre-op and Post op- 48hrs (Day 2) & Post-op Day 5.Timepoint: Immediate Preoperative, 48 hours post intervention, and postoperative Day 5;Evaluation of autoregulatory status changes and Delayed Cerebral Ischemia (DCI) of patient by trans-cranial dopplerTimepoint: Preoperatively, Postop Day 1-5 daily once;Extended Glasgow Outcome Scale scoreTimepoint: At 3 months post discharge;Observation of effect of DEX infusion on Peri-operative patient hemodynamics (Heart rate and MAP)Timepoint: At 5 min interval throughout intra-operative period

Countries

India

Contacts

Public ContactSomsubhra Pal

PGIMER, Chandigarh

zazzydude979@gmail.com9868057732

Outcome results

None listed

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