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临床试验/CTRI/2024/04/066376
CTRI/2024/04/066376尚未招募4 期

Impact of Ketamine versus Etomidate on Inflammatory Cytokines in Hemodynamically Unstable Patients Undergoing Laparotomy for Abdominal Trauma: A Randomized Controlled Trial

JPN Apex Trauma Centre AIIMS1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To compare IL-6 levels at 24 hours post operatively in hemodynamically unstable patients receiving ketamine or etomidate undergoing laparotomy for abdominal trauma.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Hemodynamically unstable patients posted for emergency exploratory laparotomy.

排除标准

  • 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.

结局指标

主要结局

To compare IL-6 levels at 24 hours post operatively in hemodynamically unstable patients receiving ketamine or etomidate undergoing laparotomy for abdominal trauma.

时间窗: 24 hours post operatively

次要结局

  • 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)

研究者

发起方
JPN Apex Trauma Centre AIIMS
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Riniki Sarma

AIIMS, Delhi

研究点 (1)

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