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Low-pressure pneumoperitoneum with deep neuromuscular blockade versus standard pressure pneumoperitoneum in patients undergoing laparoscopic cholecystectomy for gallstone disease: a non-inferiority randomized control trial

  • 2023 EAES Oral
  • Published:
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Abstract

Background

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.

Methodology

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.

Results

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.

Conclusion

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.

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Acknowledgements

We acknowledge all the surgeons under the Dept of Surgical Disciplines who contributed cases to this study, the anaesthesiologists for giving the deep neuromuscular block according to protocol and being the backbone in this study, the staff including technicians who helped in the neuromuscular monitoring and adjustment of pressure during the surgery and all the residents of the department who were part of the team.

Funding

No research funding received for the paper.

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Authors and Affiliations

  1. Department of Surgical Disciplines, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India

    Prasanna Ramana Arumugaswamy, Sunil Chumber, Yashwant Singh Rathore, Souvik Maitra, Hemanga Kumar Bhattacharjee, Virinder Kumar Bansal, Sandeep Aggarwal, Anita Dhar, Krishna Asuri, Kamal Kataria & Piyush Ranjan

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  1. Prasanna Ramana Arumugaswamy
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Correspondence to Yashwant Singh Rathore.

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Disclosures

Prasanna Ramana Arumugaswamy, Sunil Chumber, Yashwant Singh Rathore, Souvik Maitra, Hemanga Kumar Bhattacharjee, Virinder Kumar Bansal, Sandeep Aggarwal, Anita Dhar, Krishna Asuri, Kamal Kataria, and Piyush Ranjan have no conflicts of interest or financial ties to disclose.

Ethical approval

A formal ethical approval was obtained before the start of the study (IECPG- 331/28.05.2021, RT-07/23.06.2021).

Trial registration

The trial was registered with CTRI, reg no: CTRI/2021/08/035975 before the start of the study.

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An informed consent was taken from each participant.

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Presentation in conferences: It was presented in the KARL STORZ - EAES Award session during the 31st International EAES Congress, 20–23 June 2023 in Roma, Italy and awarded the KARL STORZ AWARD for the best oral paper presentation.

Supplementary Information

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Supplementary file1 (DOCX 69 kb)

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Figure S1 supplementary: Non inferiority analysis on sub groups.

Supplementary file3 (JPEG 641 kb)

Figure S2 supplementary: Intraoperative images.

Supplementary file4 (JPEG 455 kb)

Figure S3 supplementary: Pain scores up to 7 days of follow-up.

Supplementary file5 (DOCX 14 kb)

Table S1 supplementary: Comparing consultants and trainees.

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Arumugaswamy, P.R., Chumber, S., Rathore, Y.S. et al. Low-pressure pneumoperitoneum with deep neuromuscular blockade versus standard pressure pneumoperitoneum in patients undergoing laparoscopic cholecystectomy for gallstone disease: a non-inferiority randomized control trial. Surg Endosc 38, 449–459 (2024). https://doi.org/10.1007/s00464-023-10558-0

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