Joshua M. Boster MD , Steven T. Stoffel DO , S. Michael Goertzen DO , Melissa M. Rosas MD , Jerome C. Edelson MD , Michael J. Morris MD , Robert J. Walter MD , John C. Hunninghake MD , Edward T. McCann MD , Andrew M. Hersh MD , Jess T. Anderson DO
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We hypothesized that ketamine is an effective alternative to standard moderate sedation (SMS) regimens used for bronchoscopic sedation and may be preferred by patients and physicians.</div></div><div><h3>Research Question</h3><div>Is ketamine an effective alternative to SMS for flexible fiberoptic bronchoscopy?</div></div><div><h3>Study Design and Methods</h3><div>A randomized controlled trial was conducted comparing ketamine to SMS using midazolam and fentanyl for outpatient flexible fiberoptic bronchoscopy from July 2019 to March 2022. Patients who met inclusion criteria were randomized to receive either ketamine or SMS for bronchoscopic sedation. This was a single-anonymized study and the primary outcome was patient satisfaction based on the Patient Satisfaction with Sedation Instrument.</div></div><div><h3>Results</h3><div>A total of 56 patients were enrolled with 28 randomized to each cohort. 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引用次数: 0
摘要
氯胺酮具有镇痛和镇静的双重特性，加上良好的血流动力学作用，使其成为理论上理想的支气管镜镇静药物。在成人人群中缺乏证明安全性、有效性和患者/医生满意度的研究。我们假设氯胺酮是用于支气管镜镇静的标准中度镇静（SMS）方案的有效替代方案，可能是患者和医生的首选。研究问题：氯胺酮是柔性纤维支气管镜检查的有效替代品吗？研究设计与方法于2019年7月至2022年3月进行氯胺酮与咪达唑仑和芬太尼用于门诊柔性纤维支气管镜检查的随机对照试验。符合纳入标准的患者随机接受氯胺酮或SMS用于支气管镜镇静。这是一项匿名研究，主要结果是基于患者对镇静器械的满意度的患者满意度。结果共入组56例患者，每组28例。在氯胺酮组和SMS组中，基于镇静器具患者满意度的镇静副作用报告显著增加（21.8 [SD 9.1] vs 17.0 [SD 5.6], P = 0.02）；然而，总体满意度相似（5.4 [SD 4.6] vs 4.6 [SD 1.5], P = .38）。基于临床医生对镇静器具满意度的医生总体满意度在氯胺酮组中明显较差（50.9 [SD 23.2] vs 35.0 [SD 10.8], P = 0.002），镇静给药组满意度得分明显较差（26.7 [SD 12.5] vs 17.2 [SD 5.0], P≤0.001），分泌类满意度得分明显较差（2.97 [SD 1.8] vs 1.93 [SD 1.6], P = 0.02）。两组不良事件发生率无显著差异，所有手术均顺利完成。我们的研究结果表明氯胺酮在接受柔性纤维支气管镜检查的成人患者中是安全的。然而，氯胺酮的使用与患者报告的副作用增加和医生满意度下降有关。临床试验注册网站clinicaltrials .gov；否。: NCT06181188;URL: www.clinicaltrials.gov
Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy
Background
Ketamine has both analgesic and sedative properties, combined with favorable hemodynamic effects, which makes it a theoretically ideal agent for bronchoscopic sedation. Studies in the adult population that demonstrate safety, efficacy, and patient/physician satisfaction are lacking. We hypothesized that ketamine is an effective alternative to standard moderate sedation (SMS) regimens used for bronchoscopic sedation and may be preferred by patients and physicians.
Research Question
Is ketamine an effective alternative to SMS for flexible fiberoptic bronchoscopy?
Study Design and Methods
A randomized controlled trial was conducted comparing ketamine to SMS using midazolam and fentanyl for outpatient flexible fiberoptic bronchoscopy from July 2019 to March 2022. Patients who met inclusion criteria were randomized to receive either ketamine or SMS for bronchoscopic sedation. This was a single-anonymized study and the primary outcome was patient satisfaction based on the Patient Satisfaction with Sedation Instrument.
Results
A total of 56 patients were enrolled with 28 randomized to each cohort. There was a significant increase in reported sedation side effects based on the Patient Satisfaction with Sedation Instrument (21.8 [SD 9.1] vs 17.0 [SD 5.6], P = .02) in the ketamine vs SMS cohorts respectively; however, global satisfaction was similar (5.4 [SD 4.6] vs 4.6 [SD 1.5], P = .38). Physician global satisfaction based on the Clinician Satisfaction with Sedation Instrument was significantly worse in the ketamine cohort (50.9 [SD 23.2] vs 35.0 [SD 10.8], P = .002), with significantly worse satisfaction scores in the sedation administration subset (26.7 [SD 12.5] vs 17.2 [SD 5.0], P ≤ .001) and secretions produced category (2.97 [SD 1.8] vs 1.93 [SD 1.6], P = .02). There were no significant differences in adverse events, and all procedures were completed successfully.
Interpretation
Our results indicate that ketamine is safe in adult patients undergoing flexible fiberoptic bronchoscopy. However, the use of ketamine was associated with increased patient-reported side effects and decreased physician satisfaction.
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