Clinical trial NCT03420937: Deep Neuromuscular Block During General Anaesthesia in Robotic Surgery
Official title: Deep Neuromuscular Block During General Anaesthesia in Laparoscopic (and Robotic Laparoscopic) Surgery and Its Potential Benefits for Certain Physiological Parameters in Perioperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Observation of Neuromuscular Block
Complication of Ventilation Therapy
Postoperative Recovery
Keywords: deep neuromuscular block
laparoscopic surgery
robotic surgery
lung protective ventilation
respiratory functions
post-operative recovery
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Palacky University
First posted: 2018-02-05
Enrollment: 138
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this project is to show, whether the use of the deep neuromuscular block in certain laparoscopic robot-assisted surgery can positively influence main physiological functions compared to the use of standard neuromuscular block. Secondary outcome is to find out whether the targeted specific reversal of neuromuscular block by sugammadex improves and fastens the post-operative recovery of the patients.

Detailed description: Adequate muscle relaxation during general anaesthesia is crucial for easy, uncomplicated and safe laparoscopic and robot-assisted surgery. Perfect abdominal wall relaxation facilitates surgical working conditions, which makes surgery safer, faster and easier to perform. Besides this indirect advantage, there could be obvious benefit for patients. This is a result of decreased negative pathophysiological consequences of an increased intraabdominal pressure (capnoperitoneum) on important organ systems (cardiovascular, breathing system, kidneys etc.) Complete muscle relaxation during general anaesthesia can be achieved by using higher doses of rocuronium (non-depolarizing aminosteroid muscle relaxant) and special anaesthetic technique called deep neuromuscular block (DNMB). The primary focus of the project is to test the potential advantages of DNMB compared to standard relaxation technique. Safe and efficient use of NMBA is an important precondition in restoring a patient´s full muscle strength at the end of anaesthesia, to prevent effects of residual block. Modern practice of anaesthesia offers an option for complete and immediate rocuronium induced block reversal by using its specific antagonist - sugammadex. Combination of DNMB approach and sugammadex reversal also provide potential benefits for perioperative course and patient recovery after surgery. Secondary objective of the project is to verify this facts.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Informed Consent
* Elective robotic radical prostatectomy
* American Society of Anesthesiologists (ASA) status 1-3

Exclusion Criteria:

* Inability to obtain Informed ConsentAge under 18 years
* American Society of Anesthesiologists (ASA) status over 3
* Indication for rapid sequence induction, signs of difficult airway severe neuromuscular, liver or renal disease
* Known allergy to drugs used in the study
* Malignant hyperthermia (medical history)

Primary outcomes:
measure: Surgical conditions SRS
timeFrame: Perioperative period
measure: Intraabdominal pressure IAP (mmHg)
timeFrame: During surgery
Secondary outcomes:
measure: Operating theatre time (min)
timeFrame: during anesthesia
measure: Post-operative recovery
timeFrame: post-operative period (1 week)
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc
Study officials:
affiliation: University Hospital Olomouc
name: Karel Axmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
citation: Blobner M, Frick CG, Stauble RB, Feussner H, Schaller SJ, Unterbuchner C, Lingg C, Geisler M, Fink H. Neuromuscular blockade improves surgical conditions (NISCO). Surg Endosc. 2015 Mar;29(3):627-36. doi: 10.1007/s00464-014-3711-7. Epub 2014 Aug 15.
citation: 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 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13.
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citation: Carron M. Respiratory benefits of deep neuromuscular block during laparoscopic surgery in a patient with end-stage lung disease. Br J Anaesth. 2015 Jan;114(1):158-9. doi: 10.1093/bja/aeu419. No abstract available.
citation: Kilpatrick B, Slinger P. Lung protective strategies in anaesthesia. Br J Anaesth. 2010 Dec;105 Suppl 1:i108-16. doi: 10.1093/bja/aeq299.
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citation: Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.
citation: Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. Eur J Anaesthesiol. 2010 Oct;27(10):874-81. doi: 10.1097/EJA.0b013e32833d56b7.
citation: Rahe-Meyer N, Berger C, Wittmann M, Solomon C, Abels EA, Rietbergen H, Reuter DA. Recovery from prolonged deep rocuronium-induced neuromuscular blockade: A randomized comparison of sugammadex reversal with spontaneous recovery. Anaesthesist. 2015 Jul;64(7):506-12. doi: 10.1007/s00101-015-0048-0. Epub 2015 Jul 1.
citation: Kopman AF, Naguib M. Laparoscopic surgery and muscle relaxants: is deep block helpful? Anesth Analg. 2015 Jan;120(1):51-58. doi: 10.1213/ANE.0000000000000471.
citation: Carron M, Ori C. Deep Neuromuscular Blockade for Laparoscopy: A Different View. Anesth Analg. 2016 Jan;122(1):289. doi: 10.1213/ANE.0000000000000864. No abstract available.
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