Arumugaswamy Prasanna Ramana, Chumber Sunil, Rathore Yashwant Singh, Maitra Souvik, Bhattacharjee Hemanga Kumar, Bansal Virinder Kumar, Aggarwal Sandeep, Dhar Anita, Asuri Krishna, Kataria Kamal, Ranjan Piyush
Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.
Surg Endosc. 2024 Jan;38(1):449-459. doi: 10.1007/s00464-023-10558-0. Epub 2023 Nov 27.
Low-pressure pneumoperitoneum (LPP) is an attempt at improving laparoscopic surgery. However, it has the issue of poor working space for which deep neuromuscular blockade (NMB) may be a solution. There is a lack of literature comparing LPP with deep NMB to standard pressure pneumoperitoneum (SPP) with moderate NMB.
This was a single institutional prospective non-inferiority RCT, with permuted block randomization of subjects into group A and B [Group A: LPP; 8-10 mmHg with deep NMB [ Train of Four count (TOF): 0, Post Tetanic Count (PTC): 1-2] and Group B: SPP; 12-14 mmHg with moderate NMB]. The level of NMB was monitored with neuromuscular monitor with TOF count and PTC. Cisatracurium infusion was used for continuous deep NMB in group A. Primary outcome measures were the surgeon satisfaction score and the time for completion of the procedure. Secondarily important clinical outcomes were also reported.
Of the 222 patients screened, 181 participants were enrolled [F: 138 (76.2%); M: 43 (23.8%); Group A n = 90, Group B n = 91]. Statistically similar surgeon satisfaction scores (26.1 ± 3.7 vs 26.4 ± 3.4; p = 0.52) and time for completion (55.2 ± 23.4 vs 52.5 ± 24.9 min; p = 0.46) were noted respectively in groups A and B. On both intention-to-treat and per-protocol analysis it was found that group A was non-inferior to group B in terms of total surgeon satisfaction score, however, non-inferiority was not proven for time for completion of surgery. Mean pain scores and incidence of shoulder pain were statistically similar up-to 7 days of follow-up in both groups. 4 (4.4%) patients in group B and 2 (2.2%) in group A had bradycardia (p = 0.4). Four (4.4%) cases of group A were converted to group B. One case of group B converted to open surgery. Bile spills and gallbladder perforations were comparable.
LPP with deep NMB is non-inferior to SPP with moderate NMB in terms of surgeon satisfaction score but not in terms of time required to complete the procedure. Clinical outcomes and safety profile are similar in both groups. However, it could be marginally costlier to use LPP with deep NMB.
低压气腹（LPP）是改善腹腔镜手术的一种尝试。然而，它存在工作空间不足的问题，对此深度神经肌肉阻滞（NMB）可能是一种解决方案。目前缺乏将LPP联合深度NMB与标准压力气腹（SPP）联合中度NMB进行比较的文献。
这是一项单机构前瞻性非劣效性随机对照试验，采用置换区组随机化将受试者分为A组和B组[A组：LPP；8 - 10 mmHg并联合深度NMB（四个成串刺激计数（TOF）：0，强直刺激后计数（PTC）：1 - 2）；B组：SPP；12 - 14 mmHg并联合中度NMB]。使用神经肌肉监测仪通过TOF计数和PTC监测NMB水平。A组使用顺式阿曲库铵输注进行持续深度NMB。主要结局指标是外科医生满意度评分和手术完成时间。还报告了次要的重要临床结局。
在222例筛查患者中，181例参与者入组[女性：138例（76.2%）；男性：43例（23.8%）；A组n = 90，B组n = 91]。A组和B组分别观察到统计学上相似的外科医生满意度评分（26.1 ± 3.7 vs 26.4 ± 3.4；p = 0.52）和手术完成时间（55.2 ± 23.4 vs 52.5 ± 24.9分钟；p = 0.46）。在意向性分析和符合方案分析中均发现，A组在外科医生总满意度评分方面不劣于B组，然而，在手术完成时间方面未证实非劣效性。两组在随访至7天内的平均疼痛评分和肩部疼痛发生率在统计学上相似。B组4例（4.4%）患者和A组2例（2.2%）患者出现心动过缓（p = 0.4）。A组4例（4.4%）病例转为B组。B组1例转为开放手术。胆汁外溢和胆囊穿孔情况相当。
在外科医生满意度评分方面，LPP联合深度NMB不劣于SPP联合中度NMB，但在完成手术所需时间方面并非如此。两组的临床结局和安全性概况相似。然而，使用LPP联合深度NMB的成本可能略高。
