Long Yu-Qin, Shan Xi-Sheng, Feng Xiao-Mei, Liu Hong, Ji Fu-Hai, Peng Ke
Departments of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People's Republic of China.
Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, People's Republic of China.
J Pain Res. 2021 Nov 16;14:3573-3581. doi: 10.2147/JPR.S336870. eCollection 2021.
Patients undergoing major laparoscopic surgery often experience significant pain and postoperative nausea and vomiting (PONV). Deep neuromuscular block (NMB) improves surgical conditions and facilitates the application of low intra-abdominal pressure (IAP), which may be beneficial for these patients. This study is designed to determine the effects of deep NMB combined with low IAP, as compared to moderate NMB combined with standard IAP, on patients' nociceptive recovery after major laparoscopic gastrointestinal surgery.
This single-center randomized controlled trial will include 220 patients scheduled for major laparoscopic gastrointestinal surgery (lasts for ≥ 90 minutes). Patients will be randomly assigned, with a 1:1 ratio, into a deep NMB + low IAP group (train of four = 0, post-tetanic count = 1-3, IAP = 8 mmHg) and a moderate NMB + standard IAP group (train of four = 1-3, IAP = 12 mmHg). If the surgical workspace is inadequate, the surgeons can request a step increase of 1 mmHg in IAP during 3-min intervals. The upper limit of IAP will be set at 15 mmHg. Postoperative recovery will be assessed using the postoperative quality recovery scale (PQRS). The primary outcome of this trial is the PQRS nociceptive recovery (including pain and PONV) at postoperative day (POD) 1. The secondary outcomes include recovery in other PQRS domains at POD 1, and recovery in all PQRS domains in a post-anesthesia care unit, at POD 3 in the surgical wards, at hospital discharge, and at postoperative 30 days. For the sample size estimation, 110 patients in each group (220 in total) would be needed to detect an absolute increase rate of 20% in the PQRS nociceptive domain in the deep NMB + low IAP group at POD 1.
This study investigates the effects of deep NMB combined with low IAP on postoperative PQRS nociceptive recovery in patients undergoing major laparoscopic gastrointestinal surgery. We expect that this deep NMB + low IAP strategy would improve postoperative pain and PONV following major laparoscopic gastrointestinal surgery.
接受大型腹腔镜手术的患者常经历显著疼痛及术后恶心呕吐（PONV）。深度神经肌肉阻滞（NMB）可改善手术条件并便于应用低腹腔内压（IAP），这可能对这些患者有益。本研究旨在确定与中度NMB联合标准IAP相比，深度NMB联合低IAP对大型腹腔镜胃肠手术后患者伤害性感受恢复的影响。
这项单中心随机对照试验将纳入220例计划进行大型腹腔镜胃肠手术（持续时间≥90分钟）的患者。患者将按1:1比例随机分配至深度NMB+低IAP组（四个成串刺激=0，强直后计数=1-3，IAP=8 mmHg）和中度NMB+标准IAP组（四个成串刺激=1-3，IAP=12 mmHg）。如果手术操作空间不足，外科医生可要求在3分钟间隔内将IAP逐步提高1 mmHg。IAP上限设定为15 mmHg。术后恢复将使用术后质量恢复量表（PQRS）进行评估。本试验的主要结局是术后第1天（POD 1）的PQRS伤害性感受恢复情况（包括疼痛和PONV）。次要结局包括POD 1时其他PQRS领域的恢复情况，以及在麻醉后护理单元、手术病房POD 3、出院时和术后30天时所有PQRS领域的恢复情况。对于样本量估计，每组需要110例患者（共220例），以检测深度NMB+低IAP组在POD 1时PQRS伤害性感受领域绝对增加率为20%。
本研究调查了深度NMB联合低IAP对接受大型腹腔镜胃肠手术患者术后PQRS伤害性感受恢复的影响。我们预计这种深度NMB+低IAP策略将改善大型腹腔镜胃肠手术后的术后疼痛和PONV。
