| 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
|
|
|
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
|
|
|
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. |