右美托咪定-氯胺酮与右美托咪定-咪达唑仑-芬太尼用于化疗端口置入期间监护麻醉的比较：一项前瞻性随机研究。
Dexmedetomidine-ketamine versus Dexmedetomidine-midazolam-fentanyl for monitored anesthesia care during chemoport insertion: a Prospective Randomized Study.
作者信息
Chun Eun Hee, Han Myeong Jae, Baik Hee Jung, Park Hahck Soo, Chung Rack Kyung, Han Jong In, Lee Hun Jung, Kim Jong Hak
机构信息
Department of Anesthesiology and Pain Medicine, School of Medicine, Ewha Womans University, 1071 Anyangcheon-ro, Yangcheon-gu, Seoul, 07985, South Korea.
Department of Anesthesiology and Pain Medicine, CHA Gumi Medical Center, CHA University, Gumi, South Korea.
出版信息
BMC Anesthesiol. 2016 Aug 2;16(1):49. doi: 10.1186/s12871-016-0211-4.
BACKGROUND
Dexmedetomidine as a sole agent showed limited use for painful procedures due to its insufficient sedative/analgesic effect, pronounced hemodynamic instability and prolonged recovery. The aim of this study was to compare the effects of dexmedetomidine-ketamine (DK) versus dexmedetomidine-midazolam-fentanyl (DMF) combination on the quality of sedation/analgesia and recovery profiles for monitored anesthesia care (MAC).
METHODS
Fifty six patients undergoing chemoport insertion were randomly assigned to group DK or DMF. All patients received 1 μg.kg(-1) dexmedetomidine over 10 min followed by 0.2-1.0 μg.kg(-1)h(-1) in order to maintain 3 or 4 of modified Observer's Assessment of Analgesia and Sedation score checked every 3 min. At the start of dexmedetomidine infusion, patients in group DK or DMF received 0.5 mg.kg(-1) ketamine or 0.05 mg.kg(-1) midazolam + 0.5 μg.kg(-1) fentanyl intravenously, respectively. When required, rescue sedatives (0.5 mg.kg-1 of ketamine or 0.05 mg.kg-1 of midazolam) and analgesics (0.5 mg.kg-1 of ketamine or 0.5 μg.kg-1 of fentanyl) were given to the patients in DK or DMF group, respectively. The primary outcome of this study was the recovery parameters (time to spontaneous eye opening and the length of the recovery room stay). The secondary outcomes were parameters indicating quality of sedation/analgesia, cardiorespiratory variables, and satisfaction scores.
RESULTS
There were no significant differences in the onset time, time to spontaneous eye opening, recovery room stay, the incidences of inadequate analgesia, hypotension and bradycardia between the two groups. Despite lower infusion rate of dexmedetomidine, more patients in the DMF group had bispectral index (BIS) < 60 than in the DK group and vice versa for need of rescue sedatives. The satisfaction scores of patients, surgeon, and anesthesiologist in the DMF group were significantly better than the DK group.
CONCLUSIONS
The DK and DMF groups showed comparable recovery time, onset time, cardiorespiratory variables, and analgesia. However, the DMF group showed a better sedation quality and satisfaction scores despite the lower infusion rate of dexmedetomidine, and a higher incidence of BIS < 60 than the DK group.
TRIAL REGISTRATION
Clinical Trial Registry of Korea KCT0000951 , registered 12/12/2013.
背景
右美托咪定作为单一药物用于疼痛操作时，因其镇静/镇痛效果不足、明显的血流动力学不稳定和恢复时间延长，应用受限。本研究旨在比较右美托咪定-氯胺酮（DK）与右美托咪定-咪达唑仑-芬太尼（DMF）联合用药对监测麻醉护理（MAC）中镇静/镇痛质量及恢复情况的影响。
方法
56例行化疗端口置入术的患者被随机分为DK组或DMF组。所有患者在10分钟内静脉输注1μg·kg⁻¹右美托咪定，随后以0.2 - 1.0μg·kg⁻¹·h⁻¹持续输注，以便每3分钟检查一次改良的观察者镇痛和镇静评分，维持评分在3或4分。在右美托咪定输注开始时，DK组和DMF组患者分别静脉注射0.5mg·kg⁻¹氯胺酮或0.05mg·kg⁻¹咪达唑仑 + 0.5μg·kg⁻¹芬太尼。必要时，DK组和DMF组患者分别给予补救性镇静剂（0.5mg·kg⁻¹氯胺酮或0.05mg·kg⁻¹咪达唑仑）和镇痛药（0.5mg·kg⁻¹氯胺酮或0.5μg·kg⁻¹芬太尼）。本研究的主要结局为恢复参数（自主睁眼时间和恢复室停留时间）。次要结局为表明镇静/镇痛质量的参数、心肺变量和满意度评分。
结果
两组在起效时间、自主睁眼时间、恢复室停留时间、镇痛不足发生率、低血压和心动过缓发生率方面无显著差异。尽管右美托咪定输注速率较低，但DMF组中脑电双频指数（BIS）<60的患者比DK组更多，而需要补救性镇静剂的情况则相反。DMF组患者、外科医生和麻醉医生的满意度评分显著优于DK组。
结论
DK组和DMF组在恢复时间、起效时间、心肺变量和镇痛方面相当。然而，尽管右美托咪定输注速率较低，但DMF组的镇静质量和满意度评分更好，且BIS<60的发生率高于DK组。
试验注册
韩国临床试验注册中心KCT0000951，于2013年12月12日注册。
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