Department of Anesthesiology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, People's Republic of China.
Department of Pain Management, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, Fuzhou, Fujian, People's Republic of China.
BMJ Open. 2023 Nov 17;13(11):e069183. doi: 10.1136/bmjopen-2022-069183.
Stellate ganglion block (SGB) is usually used in the department of algiatry. But preoperative SGB may reduce adverse cardiovascular events in high-risk patients, although evidence remains sparse. Therefore, we aim to determine whether a single-shot postoperative SGB can reduce the incidence of myocardial injury after non-cardiac surgery (MINS) and improve recovery in patients undergoing laparoscopic radical resection for colorectal cancer.
This is an investigator-initiated, single-centre, randomised, two-arm clinical trial enrolling patients aged over 45 years and scheduled for elective laparoscopic radical colorectal surgery with at least one risk factor for MINS. A total of 950 eligible patients will be randomised into a routine or block groups. The primary outcome is the incidence of MINS. The secondary outcomes include the Visual Analogue Scale of pain during rest and movement, the incidence of delirium, quality of recovery (QOR) assessed by QOR-15, and sleep quality assessed by Richards Campbell Sleep Questionnaire. Tertiary outcomes include time to first flatus, gastrointestinal complications such as anastomotic leak or ileus, length of hospital stay, collapse incidence of severe cardiovascular and cerebrovascular complications of myocardial infarction, cardiac arrest, ischaemic or haemorrhagic stroke, and all-cause mortality within 30 days after the operation.
The protocol was approved by Medical Ethics Committee of the China-Japan Union Hospital, Jilin University (Approval number: 2021081018) prior to recruitment. The study will be performed according to the guidelines of the Declaration of Helsinki. The findings of this study will be published and presented through various scientific forums.
ChiCTR2200055319.
星状神经节阻滞(SGB)通常用于疼痛科。但术前 SGB 可能减少高危患者的不良心血管事件,尽管证据仍然很少。因此,我们旨在确定单次术后 SGB 是否可以降低非心脏手术后心肌损伤(MINS)的发生率,并改善接受腹腔镜结直肠癌症根治术的患者的恢复情况。
这是一项由研究者发起的、单中心、随机、双臂临床试验,纳入年龄超过 45 岁且至少有一个 MINS 风险因素的择期腹腔镜结直肠根治术患者。共有 950 名符合条件的患者将被随机分为常规或阻滞组。主要结局是 MINS 的发生率。次要结局包括静息和运动时疼痛的视觉模拟量表、谵妄发生率、QOR-15 评估的恢复质量(QOR)以及 Richards Campbell 睡眠问卷评估的睡眠质量。次要结局包括首次排气时间、吻合口漏或肠梗阻等胃肠道并发症、住院时间、严重心血管和脑血管并发症心肌梗死、心脏骤停、缺血性或出血性中风的塌陷发生率以及术后 30 天内的全因死亡率。
该方案在招募前获得了吉林大学中日联谊医院医学伦理委员会的批准(批准号:2021081018)。该研究将按照赫尔辛基宣言的指南进行。本研究的结果将通过各种科学论坛发表和展示。
ChiCTR2200055319。