Impact of Ketamine versus Etomidate on Inflammatory Cytokines in Hemodynamically Unstable Patients Undergoing Laparotomy for Abdominal Trauma: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- To compare IL-6 levels at 24 hours post operatively in hemodynamically unstable patients receiving ketamine or etomidate undergoing laparotomy for abdominal trauma.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Hemodynamically unstable patients posted for emergency exploratory laparotomy.
Exclusion Criteria
- •Patients with anticipated difficult airway, traumatic brain injury, burns patient.
- •Patients already intubated in emergency bay
- •Patients with ny known cardiac comorbidity
- •Allergy to ketamine or etomidate
- •Patients on anti-inflammatory medications
- •Patient refusal to consent
- •Inability to obtain consent either from patient or due to absence of LAR.
Outcomes
Primary Outcomes
To compare IL-6 levels at 24 hours post operatively in hemodynamically unstable patients receiving ketamine or etomidate undergoing laparotomy for abdominal trauma.
Time Frame: 24 hours post operatively
Secondary Outcomes
- To compare IL-6 levels between the two groups half an hour after induction and immediate post operative period.
- 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
- To compare change in Sequential Organ Failure Assessment (SOFA) score at baseline preoperatively and at 24 hours postoperatively(24 hours postoperatively)
Investigators
Riniki Sarma
AIIMS, Delhi