经鼻滴右旋美托咪啶用于甲状腺切除术后镇痛的随机对照研究

Placebo-controlled evaluation of intranasal dexmedetomidine for postoperative analgesia after thyroidectomy

摘要:

目的  探讨经鼻滴注右旋美托咪啶用于甲状腺切除术后镇痛的效果。方法  选择择期全身麻醉下行甲状腺切除术患者70例。年龄35～62岁，体重38～65 kg，ASA分级Ⅰ～Ⅱ级。采用数字表法随机分为（按1∶1分配）两组：右旋美托咪啶组（D组n =35）和安慰剂对照组（P组n =35）。D组：于离开病房时（T0）、麻醉恢复室（PACU）前（T1）、离开PACU后6、12、18、24、30、36、42和48 h（T2～9）时间点经鼻滴右旋美托咪啶30μg；P组：于D组相同的时间点经鼻滴等量的生理盐水。患者根据数字评分量表评估以下时间点的疼痛强度和疼痛缓解强度：T1及之后6 h内1次/h；6～12 h内1次/2 h；12～48 h内1次/4 h。观察主要指标是48 h总疼痛强度差异，次要指标为各时间SPID、48 h总疼痛缓解差异、各时间点疼痛强度差异、疼痛缓解强度、静脉追加吗啡注射次数、血流动力学参数以及不良反应发生情况等。结果  与P组比较，D组中SPID48的分值显著升高[（37.3±6.4）vs（25.5±4.1）；P <0.01]，差异有统计学意义。SPID分值在T1后2～48 h、总疼痛缓解差异在T1后3～48 h的各个时间点与P组比较均升高，差异有统计学意义（P <0.05）。各时间点疼痛强度差异分值在T1后1～48 h各个时间点与P组比较均升高，差异有统计学意义（P <0.05）。与P组患者比较，D组患者术后24和48 h追加吗啡次数明显减少，分别为[（1.3±1.5） vs （2.3±2.1）；P =0.024]和[（3.8±4.4） vs （1.8±2.1）；P = 0.017]，差异有统计学意义。在T0、T1时刻，两组患者血流动力学参数（DBP、SBP、HR）差异无统计学意义（P >
0.05）。然而在T2～T9时刻，同一时刻D组患者血流动力学参数更低于P组，差异有统计学意义（P <0.05）。两组中均无1例不良事件的发生。两组在术后48 h不良反应的发生情况（恶心、呕吐、心动过缓、过度镇静、呼吸抑制）比较差异无统计学意义（P >0.05）。结论  经鼻滴右旋美托咪啶能有效地缓解甲状腺切除术后疼痛程度，并且术后不良反应如恶心、呕吐等的发生率与安慰剂对照组差异无统计学意义，进而推荐经鼻右旋美托咪定作为术后镇痛的一个临床选择。

Abstract:

Objective To evaluate the analgesic efficacy of intranasal dexmedetomidine in cases underwent thyroidectomy. Methods In this randomized, placebo-controlled, double-blind trial, 70 patients, aged 35-62 years old, weighting 38-65 kg, ASA grade Ⅰ-Ⅱ, underwent thyroidectomy, were randomly devided into dexmedetomidine group (group D) and placebo group (group P). Intranasal dexmedetomidine 30 ug or saline were given before leaving ward (T0) and PACU (T1), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h (T2~9) after T1. Pain intensity (based on the 11-point NRS) and pain relief (based on a 5-point scale: 0 = no relief, 1 = a little relief, 2 = moderate relief, 3 = a lot of relief, 4 = complete relief) were accessed. The primary index was the difference of summed pain intensity over 48 hours (SPID48), and the secondary indexes included SPID at each evaluation time point, total pain relief (TOTPAR), pain intensity difference (PID), pain relief at each evaluation time point, hemodynamic variables and postoperative adverse events. Results Summed pain intensity difference over 48 hours was significantly higher in the group D than in the group P [(37.3 ± 6.4) vs (25.5 ± 4.1); P < 0.001]. Mean SPID and TOTPAR scores were significantly higher in the group D at every time point from 2 hour (SPID) and 3 hours (TOTPAR) until 48 hours (P < 0.05). The mean cumulative number of doses of IV morphine was statistically lower in the group D than in the group P for 24 hours or 48 hours [respectively (1.3 ± 1.5) vs (2.3 ± 2.1); P = 0.024; (3.8 ± 4.4) vs (1.8 ± 2.1); P = 0.017]. There was no difference of SBP, DBP and HR at T0, T1 between the two groups. Between group comparison of hemodynamic variables at the same time period from T2 to T9, group D had lower hemodynamic variables compared to group P (P < 0.05). Rate of postoperative adverse events including nausea, vomiting, beckoning bradycardia, excessive sedation, respiratory depression was similar in two groups (P > 0.05). Conclusions Intranasal dexmedetomidine is effective for the management of postoperative pain in patients underwent thyroidectomy. Postoperative adverse events such as nausea, vomiting showed no significant difference between two groups. Intranasal dexmedetomidine is recommend as a clinical choice for postoperative analgesia.