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Clinical Trials/CTRI/2025/01/079103
CTRI/2025/01/079103Not yet recruitingUnknown

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

Pooja Santhosh1 site in 1 country88 target enrollmentStarted: January 29, 2025Last updated:
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Trial Snapshot

Phase
Unknown
Status
Not yet recruiting
Sponsor
Enrollment
88
Locations
1
Primary Endpoint
Comparison of neuron-specific enolase γ (NSE γ) levels between the two study groups at the end of the study drug infusion.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Patients who fulfill the inclusion criteria will be taken in the OT, baseline sample for NSEγ and IL-6 will be initially taken, after which patient will be anaesthetised using standard anaesthesia protocol. The study drug(dexmedetomidine in study group, 0.9%normal saline in control group) will be initiated after induction at a dose of 0.3mcg/kg/hour, and continued post surgery in the ICU for 48hours. At the end of 48hour infusion in ICU, serum samples will be taken to assess NSE γ and IL-6. During the ICU stay, for 48hours - PI, ICP, eCPP will be assessed using TCD. Total number of days on mechanical ventilation, ICU days and hospital days will be assessed. Neurological status at discharge and at 3months after discharge to be assessed using mRS and GOSE.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

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

  • •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.

Outcomes

Primary Outcomes

Comparison of neuron-specific enolase γ (NSE γ) levels between the two study groups at the end of the study drug infusion.

Time Frame: Comparison of neuron-specific enolase γ (NSE γ) levels between the two study groups at the end of the study drug infusion (48hours)

Secondary Outcomes

  • To compare neurological outcome at 3 months by modified Rankin score (mRS) and Glasgow Outcome Scale- Extended (GOSE).(At 3months post hospital discharge, mRS and GOSE will be assessed.)
  • Comparison of NSE γ levels in each group at the end of study drug infusion from the baseline value.(The sample (NSE γ) 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.(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.(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.(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.(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.(At discharge from hospital, mRS and GOSE will be assessed.)

Investigators

Sponsor
Pooja Santhosh
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Pooja Santhosh

PGIMER, Chandigarh

Study Sites (1)

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