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CTRI Number  CTRI/2024/04/066376 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Effects of Ketamine and Etomidate on Inflammation in Critically Injured Patient with trauma to abdomen 
Scientific Title of Study   Impact of Ketamine versus Etomidate on Inflammatory Cytokines in Hemodynamically Unstable Patients Undergoing Laparotomy for Abdominal Trauma: A Randomized 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  Riniki Sarma 
Designation  Assistant Professor 
Affiliation  AIIMS, Delhi 
Address  Room no 122 Dept of Anesthesia JPNATC AIIMS Delhi

South
DELHI
110029
India 
Phone  84474456976  
Fax    
Email  rinikirs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Riniki Sarma 
Designation  Assistant Professor 
Affiliation  AIIMS, Delhi 
Address  Room no 122 Dept of Anesthesia JPNATC AIIMS Delhi


DELHI
110029
India 
Phone  84474456976  
Fax    
Email  rinikirs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Riniki Sarma 
Designation  Assistant Professor 
Affiliation  AIIMS, Delhi 
Address  Room no 122 Dept of Anesthesia JPNATC AIIMS Delhi


DELHI
110029
India 
Phone  84474456976  
Fax    
Email  rinikirs@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Delhi 
 
Primary Sponsor  
Name  JPN Apex Trauma Centre AIIMS 
Address  Ring Road, New Delhi, Pin-110029 
Type of Sponsor  Research institution and hospital 
 
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 Riniki Sarma  JPNATC  Room no-122, Department of Anesthesia, JP Narayan Apex Trauma Centre, AIIMS, Ring Road, New Delhi-110029
South
DELHI 
8447456976

riniki_rs@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  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 
Intervention  Induction with etomidate  All patients in this group will receive etomidate 0.3 mg/kg during induction of anesthesia in intraoperative period. 
Comparator Agent  Induction with Ketamine  All patients in this group will receive ketamine 1.5 mg/kg during induction of anesthesia in intraoperative period. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Hemodynamically unstable patients posted for emergency exploratory laparotomy.  
 
ExclusionCriteria 
Details  1. Patients with anticipated difficult airway, traumatic brain injury, burns patient.
2. Patients already intubated in emergency bay
3. Patients with ny known cardiac comorbidity
4. Allergy to ketamine or etomidate
5. Patients on anti-inflammatory medications
6. Patient refusal to consent
7. Inability to obtain consent either from patient or due to absence of LAR.
 
 
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 
To compare IL-6 levels at 24 hours post operatively in hemodynamically unstable patients receiving ketamine or etomidate undergoing laparotomy for abdominal trauma.  24 hours post operatively  
 
Secondary Outcome  
Outcome  TimePoints 
To compare IL-6 levels between the two groups half an hour after induction and immediate post operative period.

 
Half an hour after induction and immediate postoperatively 
To compare IL-10, Neutrophil lymphocyte ratio (NLR), Platelet lymphocyte ratio (PLR), Serum cortisol levels between the two groups half an hour after induction, immediate post operative and 24 hours post operatively between the two groups
 
Half an hour after induction, immediate postoperative and 24 hours postoperatively 
To compare change in Sequential Organ Failure Assessment (SOFA) score at baseline preoperatively and at 24 hours postoperatively  24 hours postoperatively 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 4 
Date of First Enrollment (India)   15/05/2024 
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="2"
Months="0"
Days="0" 
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  

Hemodynamically unstable patients with abdominal trauma are managed with damage control surgery in the form of emergency exploratory laparotomy. Studies have found that trauma and surgical stress is associated with an impaired immune response in the postoperative period, that causes altered production of pro-inflammatory cytokines, as well as inhibition of cellular responses. It has also been shown that proinflammatory and anti-inflammatory cytokines are pivotal for the acute-phase inflammatory and immunologic response induced after surgical trauma. The most important cytokines in this context are tumour necrosis factor-α (TNF-α), interleukin IL-6 and interleukin IL-10. Neutrophil-lymphocyte ratio (NLR) and Platelet-lymphocyte ratio (PLR) have also been found to be associated to inflammatory status of patients with abdominal trauma. Anaesthesia also may alter immune function with potential impact on the postoperative course

Rapid sequence induction and intubation (RSII) is recommended for anesthetic induction in these set of patients given the high risk of aspiration. Preferred induction agents are etomidate and ketamine. Both of them have been found to have some immunomodulatory function. However out of the two the better drug in influencing the immune response is not known. With this background we decided to conduct a randomized controlled trial comparing etomidate and ketamine to find out which among the two had a greater impact on inflammatory cytokines.

 
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