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CTRI Number  CTRI/2024/09/073964 [Registered on: 17/09/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "Comparing the Effects of Ketamine and Etomidate on Eye Nerve Size to Check Brain Pressure in Head Injury Patients Needing Intubation in the Emergency Room" 
Scientific Title of Study   Effect of Etomidate and Ketamine on Optic Nerve Sheath Diameter in severe Traumatic Brain Injury patients undergoing Rapid Sequence Intubation in Emergency Department: ARandomized Controlled Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr P Santhosh 
Designation  Post Graduate Student 
Affiliation  AIIMS,BHUBANESWAR 
Address  Trauma and Emergency Office New Trauma Building Department of Trauma & Emergency All India Institute Of Medical Sciences Bhubaneswar
Room no. 405 New Trauma Building Department of Trauma & Emergency All India Institute Of Medical Sciences,Bhubaneswar Sijua
Khordha
ORISSA
751019
India 
Phone  7603820760  
Fax    
Email  santhoshsp2015@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Subhasree Das 
Designation  Assistant Professor 
Affiliation  AIIMS,Bhubaneswar 
Address  Trauma and Emergency Office New Trauma Building Department of Trauma & Emergency All India Institute Of Medical Sciences Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7978885193  
Fax    
Email  drkakalee@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhasree Das 
Designation  Assistant Professor 
Affiliation  AIIMS,Bhubaneswar 
Address  Trauma and Emergency Office New Trauma Building Department of Trauma & Emergency All India Institute Of Medical Sciences Bhubaneswar

Khordha
ORISSA
751019
India 
Phone  7978885193  
Fax    
Email  drkakalee@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  NA 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Dr Subhasree Das  AIIMS Bhubaneswar  Department of Trauma and Emergency (Emergency department red-yellow zone) AIIMS Bhubaneswar Sijua,Patrapada
Khordha
ORISSA 		 7978885193

drkakalee@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUIONAL ETHICS COMMITTEE,AIIMS BHUBANESWAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S061||Traumatic cerebral edema,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Etomidate 0.3-0.5 mg/kg IV  Patients with traumatic brain injury who fit in inclusion criteria will receive Etomidate 0.3-0.5 mg/kg IV for RSI. USG guided Optic Nerve Sheath Diameter will be measured 3mm posterior to optic disc 3 min prior to the drug administration and at 5 minutes and 10 min after drug administration to check for dynamic changes. 
Intervention  Ketamine 1-2 mg/kg IV  Patients with traumatic brain injury who fit ininclusion criteria will receive Ketamine 1-2 mg/kg IV for RSI. USG guided Optic Nerve Sheath Diameter will be measured 3mm posterior to the optic disc 3min prior to the drug administration and at 5 minutes and 10 min after drug administration to check for dynamic changes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  62.00 Year(s)
Gender  Both 
Details  With traumatic brain injury
presenting to ED and requiring a rapid sequence
intubation.
Patient relatives are willing to participate in the study 
 
ExclusionCriteria 
Details  Hemodynamic instability( hyper or hypotension)
during RSI
Predicted difficult intubation by LEMON scoring
Patients with open skull injuries
Patients with eyeball globe injuries, orbital mass or
tumors.
Patients with H/O any neurosurgical procedures.
Nontraumatic brain injuries
pregnancy
Anti-edema therapy like Mannitol infusion started
before arrival at ED
Contraindication or Hypersensitivity to any used
drug.
• Other organ injury causing likelihood of low GCS 
 
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 
Average change in optic nerve sheath diameter before and after
administration of induction drugs 		 Parameters Wii be taken 3 minutes before induction ,5 and 10 minutes following induction.The patient will be followed up for next 24 hour. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Hemodynamic changes
2. Successful first pass intubation
rates
3.To check the duration of sedative efficacy among the two groups. 		 Measurements are taken just before induction and 5 minutes, 10 minutes following induction.  
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   26/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Traumatic Brain Injury(TBI) has been one of the leading causes of morbidity and mortality all around the. world. During airway management in TBI, there are chances of an increase in Intracranial pressure (ICP) due to intubation, hypoxia, and hemodynamic instability.ICP is highly dynamic and changes instantly during intubation. In the literature, there is no specific drug that provides ideal incubating conditions for acute TBI patients. To provide sedation before the procedure Etomidate has long been the drug of choice. However, Etomidate

causes adrenal suppression and increases the risk of morbidity and mortality. Ketamine has emerged as a drug of choice in many such patients recently since it does not cause hypotension, has analgesic properties and its cerebral protection effect is being studied. Ultrasonography of optic nerve sheath diameter (ONSD) has been correlated with an increase in ICP as an optic nerve sheath. However, there are no studies in the literature comparing the efficacy of these drugs on ICP changes in acute TBI patients. This study will compare both these drugs and provide a better option of induction agent for rapid sequence intubation in traumatic brain injury patients.

 
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