A Study comparing three sedative (sleep) medicines (Propofol, Midazolam, and Dexmedetomidine) for brain recovery in patients with severe head injury undergoing brain surgery

Comparison between Propofol, Dexmedetomidine and Midazolam sedation on neurological outcomes in post decompressive craniectomy traumatic brain injury patients: A prospective randomized clinical study - COMPOSED

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101130

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: Propofol infusion: Group P will receive Propofol at a dose of 0.5 0.25 mg/kg/hr and titrated based on the patient s level of sedation Control Intervention1: Dexmedetomidine infusion: G

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with isolated traumatic head injury undergoing decompressive craniectomy are admitted to the trauma ICU. 2. Age group 18-65 years. 3. Pre-op GCS greater than or equal to 9.

Exclusion criteria

Exclusion criteria: 1. Refusal of consent to participate in the study. 2. Pregnancy. 3. Patient having renal, cardiac, hepatic, or any major organ damage. 4. Known allergy to any of the sedative drugs. 5. Patient who had severe bradycardia, arrhythmia, or hypotension at presentation. 6. If the patient has to be started on Noradrenaline support or any inotropic or vasopressor support within 12 hours of starting the sedation. 7. Patients in whom sedation could not be continued for 48 hours due to persisting bradycardia or hypotension or any other adverse effects. 8. BMI greater than 30 Kg/m2.

Design outcomes

Primary

Measure	Time frame
To study the effects of propofol, dexmedetomidine, and midazolam on the neurological outcomes of post-decompressive craniectomy traumatic brain injury patients at discharge and at 3 months, defined using the extended Glasgow outcome scale (GOS-E).Timepoint: At discharge and at 3 months	—

Secondary

Measure	Time frame
1. Comparison of the ICP changes among the various study groups using Optic nerve sheath diameter (ONSD). 2. Effect on hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure). 3. Association between the use of sedative drugs and blood lactate changes in ABG. 4. Modified Rankin Scale (MRS) at discharge and 3 months post-discharge. Timepoint: The hemodynamic profile will be recorded every 5 minutes for the first 30 minutes, followed by every 10 minutes for the next 30 minutes, every 15 minutes for the next hour, and subsequently every 2 hours till 24 hours. GCS: to be recorded at baseline, pre-op, at 24 hours, 48 hours, day 3, and day 5. ABG: to be recorded at baseline, thereafter at 6, 12, 24, and 48 hours. ONSD: to be recorded at 6, 12, 24 hours, day 3, day 5, day 7.	—

Measure

Time frame

1. Comparison of the ICP changes among the various study groups using Optic nerve sheath diameter (ONSD). 2. Effect on hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure). 3. Association between the use of sedative drugs and blood lactate changes in ABG. 4. Modified Rankin Scale (MRS) at discharge and 3 months post-discharge. Timepoint: The hemodynamic profile will be recorded every 5 minutes for the first 30 minutes, followed by every 10 minutes for the next 30 minutes, every 15 minutes for the next hour, and subsequently every 2 hours till 24 hours. GCS: to be recorded at baseline, pre-op, at 24 hours, 48 hours, day 3, and day 5. ABG: to be recorded at baseline, thereafter at 6, 12, 24, and 48 hours. ONSD: to be recorded at 6, 12, 24 hours, day 3, day 5, day 7.

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Countries

India

Contacts

Public ContactDr Somsubhra Pal

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

dryashacin1999@gmail.com9918424416

Outcome results

None listed

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