Study to see if the medicine injection dexmedetomidine (an anesthesia medicine) in low doses has any beneficial effects in reducing further tissue injury in patients with brain injury due to trauma.

A randomized controlled trial to evaluate the neuroprotective effect of low-dose dexmedetomidine infusion in patients with isolated moderate to severe traumatic brain injury - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/01/079103

Enrollment

Registered

2025-01-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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: Injection Dexmedetomidine: Given as intravenous infusion for 48hours at dose of 0.3mcg/kg/hour. Control Intervention1: 0.9% normal saline: Given as intravenous infusion for 48hours at t

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with isolated moderate to severe TBI (GCS 6-12 ) 2.Patients who are posted for Decompressive Craniectomy (DC) within 24 hours of TBI 3.Age between 18 and 65 years 4.ASA IE, IIE, IIIE

Exclusion criteria

Exclusion criteria: Patients with TBI who are conservatively managed. Those with EDH. Patients who are hemodynamically unstable preoperatively. Bradycardia - heart rate less than 50beats/minute. Pregnant patients. Refusal to consent to study by patients kin. Those with renal failure, chronic liver disease, decompensated cardiac failure.

Design outcomes

Primary

Measure	Time frame
Comparison of neuron-specific enolase ? (NSE ?) levels between the two study groups at the end of the study drug infusion.Timepoint: Comparison of neuron-specific enolase ? (NSE ?) levels between the two study groups at the end of the study drug infusion (48hours)	—

Secondary

Measure	Time frame
Comparison of NSE ? levels in each group at the end of study drug infusion from the baseline value.Timepoint: The sample (NSE ?) within each group before induction is compared with the sample taken after 48hours of infusion.;Comparison of Interleukin-6 (IL-6) levels between the two study groups at the end of the study drug infusion.Timepoint: Comparison of Interleukin-6 (IL-6) levels between the two study groups at the end of the study drug infusion (48hours).;Comparison of IL-6 levels in each group at the end of study drug infusion from baseline value.Timepoint: The sample(IL-6) within each group before induction is compared with the sample taken after 48hours of infusion.;Comparison of ICP derived from Pulsatility index (PI) and estimated Cerebral Perfusion Pressure (eCPP) using TCD 12 hourly during ICU stay in both groups.Timepoint: ICP, PI, eCPP is measured every 12hours for 48hours of ICU stay.;Comparison of mechanical ventilation days, ICU days and hospital days in between the study groups.Timepoint: Number of days on ventilator support, in ICU and total days of hospital stay will be assessed.;To compare neurological outcome at discharge by modified Rankin score (mRS) and GOSE.Timepoint: At discharge from hospital, mRS and GOSE will be assessed.;To compare neurological outcome at 3 months by modified Rankin score (mRS) and Glasgow Outcome Scale- Extended (GOSE).Timepoint: At 3months post hospital discharge, mRS and GOSE will be assessed.	—

Measure

Time frame

Comparison of NSE ? levels in each group at the end of study drug infusion from the baseline value.Timepoint: The sample (NSE ?) within each group before induction is compared with the sample taken after 48hours of infusion.;Comparison of Interleukin-6 (IL-6) levels between the two study groups at the end of the study drug infusion.Timepoint: Comparison of Interleukin-6 (IL-6) levels between the two study groups at the end of the study drug infusion (48hours).;Comparison of IL-6 levels in each group at the end of study drug infusion from baseline value.Timepoint: The sample(IL-6) within each group before induction is compared with the sample taken after 48hours of infusion.;Comparison of ICP derived from Pulsatility index (PI) and estimated Cerebral Perfusion Pressure (eCPP) using TCD 12 hourly during ICU stay in both groups.Timepoint: ICP, PI, eCPP is measured every 12hours for 48hours of ICU stay.;Comparison of mechanical ventilation days, ICU days and hospital days in between the study groups.Timepoint: Number of days on ventilator support, in ICU and total days of hospital stay will be assessed.;To compare neurological outcome at discharge by modified Rankin score (mRS) and GOSE.Timepoint: At discharge from hospital, mRS and GOSE will be assessed.;To compare neurological outcome at 3 months by modified Rankin score (mRS) and Glasgow Outcome Scale- Extended (GOSE).Timepoint: At 3months post hospital discharge, mRS and GOSE will be assessed.

—

Countries

India

Contacts

Public ContactPooja Santhosh

PGIMER, Chandigarh

nidhibp@gmail.com7087009525

Outcome results

None listed

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