A clinical trial to study the effect of Propofol, Dexmedetomidine, and Midazolam Sedation on Neurological Outcomes in Conservatively Managed ICU Patients with Traumatic Brain Injury.

A Triple-Arm Study Comparing Propofol, Dexmedetomidine, and Midazolam Sedation on Neurological Outcomes in Conservatively Managed ICU Patients with Traumatic Brain Injury. - DREAM-TBI

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101047

Enrollment

Registered

2026-01-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: S061- Traumatic cerebral edema Health Condition 2: S062- Diffuse traumatic brain injury Health Condition 3: S063- Focal traumatic brain injury Health Condition 4: S064- Epidural hemorrhage Health Condition 5: S065- Traumatic subdural hemorrhage Health Condition 6: S066- Traumatic subarachnoid hemorrhage Health Condition 7: S068- Other specified intracranial injuries Health Condition 8: S069- Unspecified intracranial injury

Interventions

Intervention1: Midazolam infusion: Group C will receive Midazolam at a dose of 0.05 0.025 mg/kg/hr and titrated based on the patient s level of sedation. Control Intervention1: Propofol infusion: Grou

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with isolated traumatic head injury admitted in trauma centre 2.GCS more than or equal to 7 during admission in Trauma triage. 3.Patient having at least 1 week stay in trauma centre ICU with sedation of 48 hours.

Exclusion criteria

Exclusion criteria: 1.Refusal of consent to participate in the study. 2.Pregnancy. 3.Patient undergoing DECRA in between initial 48 hour of sedation 4.Patient having renal, cardiac,hepatic or any major organ damage. 5.Uncooperative patients. 6.Patient having opoids overdose and hypoglycemia 7.Known allergy to any of the sedative drugs. 8.Patient who had severe bradycardia, arrthymia, or hypotension at presentation.

Design outcomes

Primary

Measure	Time frame
To study the effects of Propofol, Dexmedetomidine and Midazolam on the neurological outcomes of traumatic brain injury patients managed conservatively using extended Glasgow outcome scale (GOS-E).Timepoint: At discharge and at 3 months	—

Secondary

Measure	Time frame
1.Observation of the drugs used for sedation for the effect on patient hemodynamic profile (HR , MAP, SBP and DBP). 2.Comparison of the ICP changes among the various study groups using ONSD. 3.Association between the use of sedative drugs , inflammatory biomarker qCRP , IL 6 and neurological outcome 4.Association between the use of sedative drugs and blood lactate changes. Timepoint: 1.The hemodynamic profile will be recorded every 5 min for the first 30 minutes, followed by every 10 minutes for the next 30 minutes, 15 minutes for the next hour and subsequently every 2 hourly till 48 hours. 2.GCS to be recorded at admission in Trauma Centre baseline, at 24 hours, 48 hours, day 3 and day 5. 3.ABG to be recorded at baseline, thereafter at 6, 12, 24, 48 hours. 3.ONSD to be recorded at baseline, 6, 12, 24 hours, 48 hours, day 4, day 7. 4.qCRP and IL 6 to be recorded at baseline and 48 hours	—

Measure

Time frame

1.Observation of the drugs used for sedation for the effect on patient hemodynamic profile (HR , MAP, SBP and DBP). 2.Comparison of the ICP changes among the various study groups using ONSD. 3.Association between the use of sedative drugs , inflammatory biomarker qCRP , IL 6 and neurological outcome 4.Association between the use of sedative drugs and blood lactate changes. Timepoint: 1.The hemodynamic profile will be recorded every 5 min for the first 30 minutes, followed by every 10 minutes for the next 30 minutes, 15 minutes for the next hour and subsequently every 2 hourly till 48 hours. 2.GCS to be recorded at admission in Trauma Centre baseline, at 24 hours, 48 hours, day 3 and day 5. 3.ABG to be recorded at baseline, thereafter at 6, 12, 24, 48 hours. 3.ONSD to be recorded at baseline, 6, 12, 24 hours, 48 hours, day 4, day 7. 4.qCRP and IL 6 to be recorded at baseline and 48 hours

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Countries

India

Contacts

Public ContactDr Somsubhra Pal

Institute of Medical Sciences (IMS), Banaras Hindu University (BHU)

drrajaiims86@gmail.com9643975465

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026