Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials

Gabby T J A Reijnders-Boerboom, Esmee V van Helden, Robert C Minnee, Kim I Albers, Moira H D Bruintjes, Albert Dahan, Chris H Martini, Frank C H d'Ancona, Gert-Jan Scheffer, Christiaan Keijzer, Michiel C Warlé, Gabby T J A Reijnders-Boerboom, Esmee V van Helden, Robert C Minnee, Kim I Albers, Moira H D Bruintjes, Albert Dahan, Chris H Martini, Frank C H d'Ancona, Gert-Jan Scheffer, Christiaan Keijzer, Michiel C Warlé

Abstract

Study objective: To assess whether different intensities of intra-abdominal pressure and deep neuromuscular blockade influence the risk of intra-operative surgical complications during laparoscopic donor nephrectomy.

Design: A pooled analysis of ten previously performed prospective randomized controlled trials.

Setting: Laparoscopic donor nephrectomy performed in four academic hospitals in the Netherlands: Radboudumc, Leiden UMC, Erasmus MC Rotterdam, and Amsterdam UMC.

Patients: Five hundred fifty-six patients undergoing a transperitoneal, fully laparoscopic donor nephrectomy enrolled in ten prospective, randomized controlled trials conducted in the Netherlands from 2001 to 2017.

Interventions: Moderate (tetanic count of four > 1) versus deep (post-tetanic count 1-5) neuromuscular blockade and standard (≥10 mmHg) versus low (<10 mmHg) intra-abdominal pressure.

Measurements: The primary endpoint is the number of intra-operative surgical complications defined as any deviation from the ideal intra-operative course occurring between skin incision and closure with five severity grades, according to ClassIntra. Multiple logistic regression analyses were used to identify predictors of intra- and postoperative complications.

Main results: In 53/556 (9.5%) patients, an intra-operative complication with ClassIntra grade ≥ 2 occurred. Multiple logistic regression analyses showed standard intra-abdominal pressure (OR 0.318, 95% CI 0.118-0.862; p = 0.024) as a predictor of less intra-operative complications and moderate neuromuscular blockade (OR 3.518, 95% CI 1.244-9.948; p = 0.018) as a predictor of more intra-operative complications. Postoperative complications occurred in 31/556 (6.8%), without significant predictors in multiple logistic regression analyses.

Conclusions: Our data indicate that the use of deep neuromuscular blockade could increase safety during laparoscopic donor nephrectomy. Future randomized clinical trials should be performed to confirm this and to pursue whether it also applies to other types of laparoscopic surgery.

Trial registration: Clinicaltrials.gov LEOPARD-2 (NCT02146417), LEOPARD-3 trial (NCT02602964), and RELAX-1 study (NCT02838134), Klop et al. ( NTR 3096 ), Dols et al. 2014 ( NTR1433 ).

Keywords: Artificial pneumoperitoneum; Intra-operative complications; Laparoscopy; Neuromuscular blockade; Postoperative complications.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

References

    1. Albers KI, Díaz Cambronero O, Keijzer C, Snoeck MMJ, Warlé MC, Fuchs-Buder T. Revisiting the classification of neuromuscular blockade, aligning clinical practice and research. Anesth Analg. 2019;129(5):e176–e1e8. doi: 10.1213/ANE.0000000000004407.
    1. Blobner M, Frick CG, Stauble RB, Feussner H, Schaller SJ, Unterbuchner C, et al. Neuromuscular blockade improves surgical conditions (NISCO) Surg Endosc. 2015;29(3):627–636. doi: 10.1007/s00464-014-3711-7.
    1. Bohnen JD, Mavros MN, Ramly EP, Chang Y, Yeh DD, Lee J, de Moya M, King DR, Fagenholz PJ, Butler K, Velmahos GC, Kaafarani HMA. Intraoperative adverse events in abdominal surgery: what happens in the operating room does not stay in the operating room. Ann Surg. 2017;265(6):1119–1125. doi: 10.1097/SLA.0000000000001906.
    1. Boon M, Martini C, Yang HK, Sen SS, Bevers R, Warlé M, Aarts L, Niesters M, Dahan A. Impact of high- versus low-dose neuromuscular blocking agent administration on unplanned 30-day readmission rates in retroperitoneal laparoscopic surgery. PLoS One. 2018;13(5):e0197036. doi: 10.1371/journal.pone.0197036.
    1. Bruintjes MH, van Helden EV, Braat AE, Dahan A, Scheffer GJ, van Laarhoven CJ, Warlé MC. Deep neuromuscular block to optimize surgical space conditions during laparoscopic surgery: a systematic review and meta-analysis. Br J Anaesth. 2017;118(6):834–842. doi: 10.1093/bja/aex116.
    1. Bruintjes MHD, Krijtenburg P, Martini CH, Poyck PP, d'Ancona FCH, Huurman VAL, van der Jagt M, Langenhuijsen JF, Nijboer WN, van Laarhoven C, Dahan A, Warlé MC, RELAX collaborator group Efficacy of profound versus moderate neuromuscular blockade in enhancing postoperative recovery after laparoscopic donor nephrectomy: a randomised controlled trial. Eur J Anaesthesiol. 2019;36(7):494–501. doi: 10.1097/EJA.0000000000000992.
    1. Cammu G. Residual neuromuscular blockade and postoperative pulmonary complications: what does the recent evidence demonstrate? Curr Anesthesiol Rep. 2020;10(2):131–136. doi: 10.1007/s40140-020-00388-4.
    1. Dell-Kuster S, Clavien PA, Bucher HC, Rosenthal R. Classification of intraoperative complications: reply. World J Surg. 2015;39(12):3033–3034. doi: 10.1007/s00268-015-3199-x.
    1. Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, et al. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020;370:m2917. doi: 10.1136/bmj.m2917.
    1. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205–213. doi: 10.1097/.
    1. Dols LF, Kok NF, d'Ancona FC, Klop KW, Tran TC, Langenhuijsen JF, et al. Randomized controlled trial comparing hand-assisted retroperitoneoscopic versus standard laparoscopic donor nephrectomy. Transplantation. 2014;97(2):161–167. doi: 10.1097/TP.0b013e3182a902bd.
    1. Dols LF, Kok NF, Terkivatan T, Tran KT, Alwayn IP, Weimar W, et al. Optimizing left-sided live kidney donation: hand-assisted retroperitoneoscopic as alternative to standard laparoscopic donor nephrectomy. Transpl Int. 2010;23(4):358–363. doi: 10.1111/j.1432-2277.2009.00990.x.
    1. Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014;31(8):430–436. doi: 10.1097/EJA.0000000000000094.
    1. Fuchs-Buder T, Schmartz D, Baumann C, Hilt L, Nomine-Criqui C, Meistelman C, Brunaud L. Deep neuromuscular blockade improves surgical conditions during gastric bypass surgery for morbid obesity: a randomised controlled trial. Eur J Anaesthesiol. 2019;36(7):486–493. doi: 10.1097/EJA.0000000000000996.
    1. Honing GHM, Reijnders-Boerboom GTJA, Dell-Kuster S, Van Velzen M, Martini CH, Valenza F, Proto P, Díaz Cambronero O, Broens S, Panhuizen I, Roozekrans M, Fuchs-Buder T, Boon M, Dahan A, Warlé MC. The impact of deep versus standard neuromuscular block on intra-operative safety during laparoscopic surgery: an international multicenter randomized controlled double-blind strategy trial (EURO-RELAX). Trials 2021;22:744. 10.1186/s13063-021-05638-2.
    1. Gurusamy KS, Samraj K, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2009;(2):Cd006930. 10.1002/14651858.CD006930.pub2.
    1. Hu YY, Arriaga AF, Roth EM, Peyre SE, Corso KA, Swanson RS, Osteen RT, Schmitt P, Bader AM, Zinner MJ, Greenberg CC. Protecting patients from an unsafe system: the etiology and recovery of intraoperative deviations in care. Ann Surg. 2012;256(2):203–210. doi: 10.1097/SLA.0b013e3182602564.
    1. Kaafarani HM, Velmahos GC. Classification of intraoperative complications. World J Surg. 2015;39(12):3032. doi: 10.1007/s00268-015-3119-0.
    1. Kim MH, Lee KY, Lee KY, Min BS, Yoo YC. Maintaining optimal surgical conditions with low insufflation pressures is possible with deep neuromuscular blockade during laparoscopic colorectal surgery: a prospective, randomized, double-blind, parallel-group clinical trial. Medicine. 2016;95(9):e2920. doi: 10.1097/MD.0000000000002920.
    1. Kinaci E, Sevinc MM, Bayrak S, Erdogan E, Ozakay A, Sari S. Is the classification of intraoperative complications (CLASSIC) related to postoperative course? Int J Surgery (London, England) 2016;29:171–175. doi: 10.1016/j.ijsu.2016.03.068.
    1. Klop KW, Kok NF, Dols LF, Dor FJ, Tran KT, Terkivatan T, et al. Can right-sided hand-assisted retroperitoneoscopic donor nephrectomy be advocated above standard laparoscopic donor nephrectomy: a randomized pilot study. Transpl Int. 2014;27(2):162–169. doi: 10.1111/tri.12226.
    1. Kok NF, Alwayn IP, Lind MY, Tran KT, Weimar W, JN IJ. Donor nephrectomy: mini-incision muscle-splitting open approach versus laparoscopy. Transplantation. 2006;81(6):881–887. doi: 10.1097/01.tp.0000203320.74256.fd.
    1. Kok NF, Lind MY, Hansson BM, Pilzecker D, Mertens zur Borg IR, Knipscheer BC, et al. Comparison of laparoscopic and mini incision open donor nephrectomy: single blind, randomised controlled clinical trial. BMJ. 2006b;333(7561):221. 10.1136/bmj.38886.618947.7C.
    1. Koo BW, Oh AY, Seo KS, Han JW, Han HS, Yoon YS. Randomized clinical trial of moderate versus deep neuromuscular block for low-pressure pneumoperitoneum during laparoscopic cholecystectomy. World J Surg. 2016;40(12):2898–2903. doi: 10.1007/s00268-016-3633-8.
    1. la Chapelle CF, Bemelman WA, Rademaker BM, van Barneveld TA, Jansen FW. A multidisciplinary evidence-based guideline for minimally invasive surgery: part 1: entry techniques and the pneumoperitoneum. Gynecol Surg. 2012;9(3):271–282. doi: 10.1007/s10397-012-0731-y.
    1. Lindekaer AL, Halvor Springborg H, Istre O. Deep neuromuscular blockade leads to a larger intraabdominal volume during laparoscopy. J Vis Exp. 2013;76(76):50045. doi: 10.3791/50045.
    1. Madsen MV, Gatke MR, Springborg HH, Rosenberg J, Lund J, Istre O. Optimising abdominal space with deep neuromuscular blockade in gynaecologic laparoscopy--a randomised, blinded crossover study. Acta Anaesthesiol Scand. 2015;59(4):441–447. doi: 10.1111/aas.12493.
    1. Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014;112(3):498–505. doi: 10.1093/bja/aet377.
    1. Minnee RC, Bemelman WA, Maartense S, Bemelman FJ, Gouma DJ, Idu MM. Left or right kidney in hand-assisted donor nephrectomy? A randomized controlled trial. Transplantation. 2008;85(2):203–208. doi: 10.1097/TP.0b013e3181601486.
    1. Mitropoulos D, Artibani W, Biyani CS, Bjerggaard Jensen J, Roupret M, Truss M. Validation of the Clavien-Dindo grading system in urology by the European Association of Urology guidelines ad hoc panel. Eur Urol Focus. 2018;4(4):608–613. doi: 10.1016/j.euf.2017.02.014.
    1. Neudecker J, Sauerland S, Neugebauer E, Bergamaschi R, Bonjer HJ, Cuschieri A, Fuchs KH, Jacobi C, Jansen FW, Koivusalo AM, Lacy A, McMahon MJ, Millat B, Schwenk W. The European Association for Endoscopic Surgery clinical practice guideline on the pneumoperitoneum for laparoscopic surgery. Surg Endosc. 2002;16(7):1121–1143. doi: 10.1007/s00464-001-9166-7.
    1. Özdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warlé MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016;30(5):2049–2065. doi: 10.1007/s00464-015-4454-9.
    1. Özdemir-van Brunschot DMD, Braat AE, van der Jagt MFP, Scheffer GJ, Martini CH, Langenhuijsen JF, et al. Deep neuromuscular blockade improves surgical conditions during low-pressure pneumoperitoneum laparoscopic donor nephrectomy. Surg Endosc. 2018;32(1):245–251. doi: 10.1007/s00464-017-5670-2.
    1. Özdemir-van Brunschot DMD, Scheffer GJ, van der Jagt M, Langenhuijsen H, Dahan A, Mulder J, et al. Quality of recovery after low-pressure laparoscopic donor nephrectomy facilitated by deep neuromuscular blockade: a randomized controlled study. World J Surg. 2017;41(11):2950–2958. doi: 10.1007/s00268-017-4080-x.
    1. Pansard JL, Chauvin M, Lebrault C, Gauneau P, Duvaldestin P. Effect of an intubating dose of succinylcholine and atracurium on the diaphragm and the adductor pollicis muscle in humans. Anesthesiology. 1987;67(3):326–330. doi: 10.1097/00000542-198709000-00008.
    1. Rosenthal R, Hoffmann H, Clavien PA, Bucher HC, Dell-Kuster S. Definition and classification of intraoperative complications (CLASSIC): Delphi study and pilot evaluation. World J Surg. 2015;39(7):1663–1671. doi: 10.1007/s00268-015-3003-y.
    1. Singla S, Mittal G, Raghav, Mittal RK. Pain management after laparoscopic cholecystectomy-a randomized prospective trial of low pressure and standard pressure pneumoperitoneum. J Clin Diagn Res 2014;8(2):92-94.
    1. Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gätke MR. Surgical space conditions during low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular blockade: a randomized clinical study. Anesth Analg. 2014;119(5):1084–1092. doi: 10.1213/ANE.0000000000000316.
    1. Torensma B, Martini CH, Boon M, Olofsen E, In’t Veld B, Liem RS, et al. Deep neuromuscular block improves surgical conditions during bariatric surgery and reduces postoperative pain: a randomized double-blind controlled trial. PLoS One. 2016;11(12):e0167907. doi: 10.1371/journal.pone.0167907.
    1. Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015;59(4):434–440. doi: 10.1111/aas.12491.
    1. Warlé MC, Berkers AW, Langenhuijsen JF, van der Jagt MF, Dooper PM, Kloke HJ, Pilzecker D, Renes SH, Wever KE, Hoitsma AJ, van der Vliet JA, D'Ancona FCH. Low-pressure pneumoperitoneum during laparoscopic donor nephrectomy to optimize live donors’ comfort. Clin Transplant. 2013;27(4):E478–E483. doi: 10.1111/ctr.12143.
    1. Yoo YC, Kim NY, Shin S, Choi YD, Hong JH, Kim CY, Park HJ, Bai SJ. The intraocular pressure under deep versus moderate neuromuscular blockade during low-pressure robot assisted laparoscopic radical prostatectomy in a randomized trial. PLoS One. 2015;10(8):e0135412. doi: 10.1371/journal.pone.0135412.

Source: PubMed

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