Department of Anesthesiology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
National Medical Products Administration Key Laboratory for Research and Evaluation of Narcotic and Psychotropic Drugs, Xuzhou Medical University, Xuzhou, China.
JAMA Netw Open. 2024 Apr 1;7(4):e246589. doi: 10.1001/jamanetworkopen.2024.6589.
Perioperative anxiety is prevalent among patients undergoing surgical treatment of cancer and often influences their prognosis. Transcranial direct current stimulation (tDCS) has shown potential in the treatment of various anxiety-related disorders, but data on the impact of tDCS on perioperative anxiety are limited.
To evaluate the effect of tDCS in reducing perioperative anxiety among patients undergoing laparoscopic colorectal cancer (CRC) resection.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted from March to August 2023 at the Affiliated Hospital of Xuzhou Medical University. Patients aged 18 years or older undergoing elective laparoscopic radical resection for CRC were randomly assigned to either the active tDCS group or the sham tDCS group. Intention-to-treat data analysis was performed in September 2023.
Patients were randomly assigned to receive 2 sessions of either active tDCS or sham tDCS over the left dorsolateral prefrontal cortex on the afternoon of the day before the operation and in the morning of the day of operation.
The main outcome was the incidence of perioperative anxiety from the day of the operation up to 3 days after the procedure, as measured using the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale (range: 0-21, with higher scores indicating more anxiety). Secondary outcomes included postoperative delirium (assessed by the Confusion Assessment Method or Confusion Assessment Method intensive care unit scale); pain (assessed by the 10-point Numeric Rating Scale [NRS], with scores ranging from 0 [no pain] to 10 [worst pain]); frailty (assessed by the Fatigue, Resistance, Ambulation, Illness and Loss of Weight [FRAIL] Index, with scores ranging from 0 [most robust] to 5 [most frail]; and sleep quality (assessed by the Pittsburgh Sleep Quality Index [PSQI], with scores ranging from 0 to 21 and higher scores indicating worse sleep quality) after the 2 sessions of the tDCS intervention.
A total of 196 patients (mean [SD] age, 63.5 [11.0] years; 124 [63.3%] men) were recruited and randomly assigned to the active tDCS group (98 patients) or the sham tDCS group (98 patients). After the second tDCS intervention on the day of the operation, the incidence of perioperative anxiety was 38.8% in the active tDCS group and 70.4% in the sham tDCS group (relative risk, 0.55 [95% CI, 0.42-0.73]; P < .001). Patients in the active tDCS group vs the sham tDCS group were less likely to have postoperative delirium (8.2% vs 25.5%) and, at 3 days after the operation, had lower median (IQR) pain scores (NRS, 1.0 [1.0-1.0] vs 2.0 [2.0-2.0]), better median (IQR) sleep quality scores (PSQI, 10.5 [10.0-11.0] vs 12.0 [11.0-13.0]), and lower median (IQR) FRAIL Index (2.0 [1.0-2.0] vs 2.0 [2.0-3.0]).
Findings of this randomized clinical trial indicate that administration of 2 preoperative sessions of tDCS was associated with a decreased incidence of perioperative anxiety in patients undergoing elective CRC resection. Active tDCS was also associated with better anxiety scores, pain levels, and sleep quality as well as reduced postoperative delirium and frailty. The findings suggest that tDCS may be a novel strategy for improving perioperative anxiety in patients undergoing CRC resection.
Chinese Clinical Trial Register Identifier: ChiCTR2300068859.
围手术期焦虑在接受癌症手术治疗的患者中普遍存在,常影响其预后。经颅直流电刺激(tDCS)已显示出在治疗各种焦虑相关障碍方面的潜力,但关于 tDCS 对围手术期焦虑影响的数据有限。
评估 tDCS 对腹腔镜结直肠癌(CRC)切除患者围手术期焦虑的影响。
设计、地点和参与者:这是一项于 2023 年 3 月至 8 月在徐州医科大学附属医院进行的随机临床试验。招募了年龄在 18 岁及以上、择期行腹腔镜根治性结直肠切除术的患者,随机分为 tDCS 组或假 tDCS 组。2023 年 9 月进行意向治疗数据分析。
患者在手术前一天下午和手术当天早上随机接受 2 次 tDCS 或假 tDCS 治疗,刺激部位为左侧背外侧前额叶皮质。
主要结局是从手术当天到术后 3 天期间围手术期焦虑的发生率,采用医院焦虑和抑郁量表-焦虑(HADS-A)分量表(范围:0-21,分数越高表示焦虑越严重)进行测量。次要结局包括术后谵妄(采用意识混乱评估方法或重症监护病房意识混乱评估方法进行评估);疼痛(采用 10 分数字评分量表[NRS]进行评估,得分范围为 0[无痛]至 10[最痛]);衰弱(采用疲劳、抵抗、活动、疾病和体重减轻[FRAIL]指数进行评估,得分范围为 0[最强壮]至 5[最虚弱]);睡眠质量(采用匹兹堡睡眠质量指数[PSQI]进行评估,得分范围为 0 至 21,得分越高表示睡眠质量越差)。在接受 tDCS 干预后的 2 次治疗后进行测量。
共纳入 196 例患者(平均[标准差]年龄 63.5[11.0]岁;124 例[63.3%]男性),随机分为 tDCS 组(98 例)或假 tDCS 组(98 例)。在手术当天的第二次 tDCS 干预后,tDCS 组的围手术期焦虑发生率为 38.8%,假 tDCS 组为 70.4%(相对风险 0.55[95%CI,0.42-0.73];P<0.001)。与假 tDCS 组相比,tDCS 组患者术后谵妄发生率较低(8.2% vs 25.5%),且术后第 3 天疼痛评分(NRS)中位数(IQR)较低(1.0[1.0-1.0] vs 2.0[2.0-2.0]),睡眠质量评分(PSQI)中位数(IQR)较好(10.5[10.0-11.0] vs 12.0[11.0-13.0]),衰弱指数(FRAIL)中位数(IQR)较低(2.0[1.0-2.0] vs 2.0[2.0-3.0])。
这项随机临床试验的结果表明,对择期行结直肠癌切除术的患者进行 2 次术前 tDCS 治疗与降低围手术期焦虑发生率有关。与假 tDCS 相比,tDCS 还与更好的焦虑评分、疼痛水平和睡眠质量以及降低术后谵妄和衰弱相关。这些发现表明,tDCS 可能是改善结直肠癌切除术患者围手术期焦虑的一种新策略。
中国临床试验注册中心标识符:ChiCTR2300068859。