Effect of Intraoperative and Postoperative Infusion of Dexmedetomidine on the Quality of Postoperative Analgesia in Highly Nicotine-Dependent Patients After Thoracic Surgery: A CONSORT-Prospective, Randomized, Controlled Trial.
Effect of Intraoperative and Postoperative Infusion of Dexmedetomidine on the Quality of Postoperative Analgesia in Highly Nicotine-Dependent Patients After Thoracic Surgery: A CONSORT-Prospective, Randomized, Controlled Trial.
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术中和术后输注右美托咪定对胸外科高度尼古丁依赖患者术后镇痛质量的影响：一项 CONSORT 前瞻性、随机、对照试验。
DOI：
10.1097/md.0000000000001329
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发表时间：
2015-08
期刊：
影响因子：
1.6
通讯作者：
Qi F
中科院分区：
文献类型：
--
作者：
Ren C;Zhang X;Liu Z;Li C;Zhang Z;Qi F
吸烟是世界上最常见的成瘾之一。吸入尼古丁可增加患心肺疾病的风险。然而，对于接受胸外科手术的高度尼古丁依赖患者，改善术后镇痛的解决方案尚未得到具体解决。这项CONSORT前瞻性、随机化、双盲、对照试验研究了右美托咪定和舒芬太尼联合治疗胸外科手术后高度尼古丁（尼古丁依赖的Fagerstrom试验≥6）依赖患者的疗效。2014年2月至2014年11月期间，对174例接受胸外科手术的男性患者进行了筛选，共排除了49例患者。在这项双盲、随机研究中，132例接受胸部手术并接受术后患者自控静脉镇痛的高度尼古丁依赖男性患者在术后被分为3组：舒芬太尼（0.02 μg/kg/h，S组）、舒芬太尼+右美托咪定（各0.02 μg/kg/h，D1组）或舒芬太尼（0.02 μg/kg/h）+右美托咪定（0.04 μg/kg/h）（D2组）。 作为我们的回顾性研究，患者自控镇痛（PCA）程序被编程为输送2 ml的推注剂量，背景输注为2 ml/h，锁定时间为5 min，4小时限制为40 ml。 主要结局指标为自我给药舒芬太尼的累积量;次要结局指标为疼痛强度（数字评定量表，NRS）、镇静水平（LOS）、Bruggrmann舒适量表（BCS）、功能活动评分（FAS）和相关不良反应。术后72 h内，D2组舒芬太尼自给药量低于S组和D1组（P <0.05），D1组舒芬太尼总用量和单位体重用量仅在术后4、8、16 h显著低于S组（P <0.05）。 与S组相比，D2组术后1、4、8 h静息状态及术后4、8、16、24 h咳嗽状态下NRS评分均显著降低（P <0.05）。 与D1组相比，D2组术后4、8h静息状态及咳嗽时NRS评分均显著降低（P <0.05）。 D1组与S组术后各时间点静息及咳嗽时NRS评分差异均无统计学意义（P> 0.05）。 D2组术后1h的LOS高于S组和D1组（P <0.05），术后4、8、16 h的BCS高于S组和D1组（P <0.05），术后48、72 h的FAS高于S组和D1组（P <0.05）。 术后72 h内D2组的镇痛次数明显少于S组和D1组（P <0.05）。 除瘙痒外，3组患者的基线临床特征和术后不良反应差异无统计学意义（P> 0.05）。 在测试的患者自控镇痛选项中，在胸部手术后的最初72小时内，添加右美托咪定（0.04 μg/kg/h）和舒芬太尼（0.02 μg/kg/h）显示出更好的镇痛效果和更高的患者满意度，且高度尼古丁依赖患者无其他临床相关副作用。 试验注册：chictr.org（ChiCTR-TRC-14004191）。
Smoking is one of the most common addictions in the world. Nicotine inhalation could increase the risk of cardiorespiratory diseases. However, the solution that improved postoperative analgesia for highly nicotine-dependent patients undergoing thoracic surgery has not been specifically addressed. This CONSORT-prospective, randomized, double-blinded, controlled trial investigated the efficacy of combination of dexmedetomidine and sufentanil for highly nicotine (Fagerstrom test of nicotine dependence ≥6)-dependent patients after thoracic surgery. One hundred seventy-four male patients who underwent thoracic surgery were screened between February 2014 and November 2014, and a total of forty-nine were excluded. One hundred thirty-two highly nicotine-dependent male patients who underwent thoracic surgery and received postoperative patient-controlled intravenous analgesia were divided into 3 groups after surgery in this double-blind, randomized study: sufentanil (0.02 μg/kg/h, Group S), sufentanil plus dexmedetomidine (0.02 μg/kg/h each, Group D1), or sufentanil (0.02 μg/kg/h) plus dexmedetomidine (0.04 μg/kg/h) (Group D2). The patient-controlled analgesia (PCA) program was programmed to deliver a bolus dose of 2 ml, with background infusion of 2 ml/h and a lockout of 5 min, 4-hour limit of 40 ml, as our retrospective study. The primary outcome measure was the cumulative amount of self-administered sufentanil; the secondary outcome measures were pain intensity (numerical rating scale, NRS), level of sedation (LOS), Bruggrmann comfort scale (BCS), functional activity score (FAS), and concerning adverse effects. The amount of self-administered sufentanil were lower in group D2 compared with S and D1 groups during the 72 hours after surgery (P < 0.05), whereas the total dosage and dosage per body weight of sufentanil were significantly lower in D1 group than that of S group only at 4, 8, and 16 hours after surgery (P < 0.05). Compared with S group, the NRS scores at rest at 1, 4, and 8 hours after surgery and with coughing at 4, 8, 16, and 24 hours after surgery were significantly lower in D2 group (P < 0.05). However, compared with D1 group, the NRS scores both at rest and with coughing at 4 and 8 hours after surgery were significantly lower in D2 group (P < 0.05). The NRS scores both at rest and with coughing show that there were no significant differences between D1 group and S group at each time point after surgery (P > 0.05). LOS of group D2 was higher than S and D1 groups at 1 hour after surgery (P < 0.05), BCS of group D2 was higher than S and D1 groups at 4, 8, and 16 hours after surgery (P < 0.05), and FAS of group D2 was higher than S and D1 groups at 48 and 72 hours after surgery (P < 0.05). The number of rescue analgesia during 72 hours after surgery in D2 group was lower than S and D1 groups (P < 0.05). There were no significant differences among the 3 groups in terms of baseline clinical characteristics and postoperative adverse effects except for itching (P > 0.05). Among the tested patient-controlled analgesia options, the addition of dexmedetomidine (0.04 μg/kg/h) and sufentanil (0.02 μg/kg/h) showed better analgesic effect and greater patient satisfaction without other clinically relevant side effects for highly nicotine-dependent patients during the initial 72 hours after thoracic surgery. Trial Registration: chictr.org (ChiCTR-TRC-14004191).