From the Department of Anesthesiology and Perioperative Medicine (N.J.S., W.T.N., D.R.B., B.P.), Division of Pulmonary and Critical Care Medicine (A.G.D.M., S.S.H., R.A.O., V.N.I., O.G., P.R.B.), Department of Biostatistics (D.R.S.), and Hemodynamic and Airway Management Group (HEMAIR) (N.J.S., D.R.B., O.G.), Mayo Clinic, Rochester, Minnesota.
J Trauma Acute Care Surg. 2019 Oct;87(4):883-891. doi: 10.1097/TA.0000000000002448.
Periintubation hypotension is associated with poor outcomes in the critically ill. We aimed to determine if an admixture of ketamine and propofol for emergent endotracheal intubation in critically ill patients was superior to etomidate. Primary endpoint was the change in mean arterial pressure from baseline to 5 minutes postdrug administration.
Emergent-use, stratified (shock status and unit type), multiunit, randomized, parallel-group superiority clinical trial was conducted at a tertiary academic medical center. Adult medical/surgical and transplant/oncologic intensive care unit patients undergoing emergent intubation were assigned randomly to receive either ketamine/propofol admixture (0.5 mg/kg of ketamine and propofol each) or reduced dose etomidate (0.15 mg/kg) for emergent intubation.
One hundred sixty participants were randomized, and 152 (79 ketamine/propofol admixture, 73 etomidate) were included in the intention-to-treat analysis. There was no statistically significant difference in mean arterial pressure change from baseline to 5 minutes postdrug administration (treatment difference [ketamine/propofol admixture-etomidate]: -2.1 mm Hg; 95% confidence interval, -6.9 mm Hg to +2.7 mm Hg; p = 0.385). In addition, no statistically significant difference was demonstrated in the change of mean arterial pressure from baseline at 10 minutes and 15 minutes postdrug administration, no statistical difference in the use of new-onset vasoactive agents or difficulty of intubation between groups. More patients in the etomidate group required non-red blood cell transfusions (16 [22%] vs. 8 [10%], p = 0.046). For patients who had adrenal testing performed, more patients in the etomidate group developed immediate adrenal insufficiency (13 [81%] of 16 vs. 5 [38%] of 13, p = 0.027). Serious adverse events were rare, 2 (3%) (cardiac arrest, hypotension) in ketamine/propofol admixture and 4 (5%) (hypertension, hypotension) in etomidate (p = 0.430).
In a heterogeneous critically ill population, ketamine/propofol admixture was not superior to a reduced dose of etomidate at preserving per-intubation hemodynamics and appears to be a safe alternative induction agent in the critically ill.
Therapeutic/Care Management, level II.
ClinicalTrials.gov, NCT02105415, Ketamine/Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial, IRB 13-000506, Trial Registration: March 31, 2014.
围插管期低血压与危重病患者的不良结局有关。我们旨在确定氯胺酮和丙泊酚混合物在紧急气管插管中是否优于依托咪酯。主要终点是从基线到药物给药后 5 分钟时平均动脉压的变化。
在一家三级学术医疗中心进行了紧急使用、分层（休克状态和单位类型）、多单位、随机、平行组优势临床试验。接受紧急插管的成年内科/外科和移植/肿瘤重症监护病房患者被随机分配接受氯胺酮/丙泊酚混合物（每公斤 0.5 毫克氯胺酮和丙泊酚）或小剂量依托咪酯（0.15 毫克/公斤）用于紧急插管。
160 名参与者被随机分配，152 名（氯胺酮/丙泊酚混合物 79 名，依托咪酯 73 名）被纳入意向治疗分析。从基线到药物给药后 5 分钟时平均动脉压的变化没有统计学意义（治疗差异[氯胺酮/丙泊酚混合物-依托咪酯]：-2.1mmHg；95%置信区间，-6.9mmHg 至+2.7mmHg；p=0.385）。此外，在药物给药后 10 分钟和 15 分钟时平均动脉压的变化、两组间新出现的血管活性药物的使用或插管难度均无统计学差异。依托咪酯组需要非红细胞输血的患者更多（16 [22%] 比 8 [10%]，p=0.046）。对于接受肾上腺功能检测的患者，依托咪酯组中更多的患者出现即刻肾上腺功能不全（13 [81%] 比 16 [13%]，p=0.027）。严重不良事件罕见，氯胺酮/丙泊酚混合物组 2 例（3%）（心跳骤停，低血压），依托咪酯组 4 例（5%）（高血压，低血压）（p=0.430）。
在异质危重病患者中，氯胺酮/丙泊酚混合物在维持围插管期血液动力学方面并不优于小剂量依托咪酯，并且似乎是危重病患者中一种安全的替代诱导剂。
治疗/护理管理，II 级。
ClinicalTrials.gov，NCT02105415，氯胺酮/丙泊酚混合物“Ketofol”在危重病患者中的诱导作用与依托咪酯的比较：KEEP PACE 试验，IRB 13-000506，试验注册：2014 年 3 月 31 日。
