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CTRI Number  CTRI/2025/01/079103 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 18/01/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   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. 
Scientific Title of Study   A randomized controlled trial to evaluate the neuroprotective effect of low-dose dexmedetomidine infusion in patients with isolated moderate to severe traumatic brain injury  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Santhosh 
Designation  DM Senior Resident  
Affiliation  PGIMER, Chandigarh  
Address  Division of Neuroanaesthesia and Neurocritical Care, Department of Anaesthesia and Critical Care, PGIMER, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  8762032875  
Fax    
Email  pooja.santhosh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Nidhi B Panda 
Designation  Head, Division of Neuroanaesthesia and Neurocritical Care  
Affiliation  PGIMER, Chandigarh  
Address  Division of Neuroanaesthesia and Neurocritical Care, Department of Anaesthesia and Critical Care, PGIMER, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009525  
Fax    
Email  nidhibp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pooja Santhosh 
Designation  DM Senior Resident  
Affiliation  PGIMER, Chandigarh  
Address  Division of Neuroanaesthesia and Neurocritical Care, Department of Anaesthesia and Critical Care, PGIMER, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  8762032875  
Fax    
Email  pooja.santhosh@gmail.com  
 
Source of Monetary or Material Support  
Division of Neuroanaesthesia and Neurocritical Care, Department of Anaesthesia and Critical Care, PGIMER, Chandigarh, India 160012 
 
Primary Sponsor  
Name  Pooja Santhosh  
Address  Senior Resident, Division of Neuroanaesthesia and Neurocritical Care, Department of Anaesthesia and Critical Care, PGIMER, Chandigarh, India 160012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPooja Santhosh   Neurotrauma OT-3 and Trauma Intensive Care Unit (TICU), Advanced Trauma Centre (ATC)  Level 3, Advanced Trauma Centre, PGIMER, Madhya Marg, Sector 12, Chandigarh, India
Chandigarh
CHANDIGARH 		 8762032875

pooja.santhosh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% normal saline  Given as intravenous infusion for 48hours at the same rate as 0.3mcg/kg/hour. 
Intervention  Injection Dexmedetomidine   Given as intravenous infusion for 48hours at dose of 0.3mcg/kg/hour. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of neuron-specific enolase γ (NSE γ) levels between the two study groups at the end of the study drug infusion.   Comparison of neuron-specific enolase γ (NSE γ) levels between the two study groups at the end of the study drug infusion (48hours) 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
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.  
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   29/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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