Deep Neuromuscular Block During General Anaesthesia in Robotic Surgery
NCT ID: NCT03420937
Last Updated: 2018-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
138 participants
INTERVENTIONAL
2016-06-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Deep Neuromuscular Block
Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Post-tetanic Count (PTC) = 1-2; PTC measurement every 4 min.
Intervention: Neuromuscular blockade reversal at the end of anesthesia: sugammadex 2 mg/kg iv (when PTC is 18-20 and TOF-count 0) or sugammadex 4 mg/kg iv (when PTC under 18).
Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1,5-2,5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv.
Extubation when patient is conscious and attained recovery from neuromuscular blockade to a TOF-ratio of at least 0,9.
Sugammadex
Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.
Moderate Neuromuscular Block
Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Train-of-Four (TOF) count = 1-2, TOF-count measurement every 1 min. Intervention: Neuromuscular blockade reversal at the end of anesthesia: neostigmine 0.03 mg/kg iv + atropine 0.5-1.0 mg iv Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1.5-2.5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv Extubation when patient is conscious and attained the recovery from neuromuscular blockade to a TOF-ratio of at least 0,9.
Neostigmine, Atropin Biotika
Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.
Interventions
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Sugammadex
Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.
Neostigmine, Atropin Biotika
Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed Consent
* Elective robotic radical prostatectomy
* American Society of Anesthesiologists (ASA) status 1-3
Exclusion Criteria
* 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)
18 Years
MALE
No
Sponsors
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Palacky University
OTHER
University Hospital Olomouc
OTHER
Responsible Party
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MUDr. Lenka Doubravska
MUDr. Lenka Doubravská
Principal Investigators
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Karel Axmann, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Olomouc
Locations
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Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc
Olomouc, , Czechia
Countries
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References
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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.
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.
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.
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 Apr;59(4):441-7. doi: 10.1111/aas.12493. Epub 2015 Mar 1.
Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gatke MR. Surgical space conditions during low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular blockade: a randomized clinical study. Anesth Analg. 2014 Nov;119(5):1084-92. doi: 10.1213/ANE.0000000000000316.
Gerges FJ, Kanazi GE, Jabbour-Khoury SI. Anesthesia for laparoscopy: a review. J Clin Anesth. 2006 Feb;18(1):67-78. doi: 10.1016/j.jclinane.2005.01.013.
Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13.
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.
Kilpatrick B, Slinger P. Lung protective strategies in anaesthesia. Br J Anaesth. 2010 Dec;105 Suppl 1:i108-16. doi: 10.1093/bja/aeq299.
Futier E, Constantin JM, Jaber S. Protective lung ventilation in operating room: a systematic review. Minerva Anestesiol. 2014 Jun;80(6):726-35. Epub 2013 Nov 13.
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.
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.
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.
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.
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.
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 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.
Other Identifiers
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IGA_LF_2016_021
Identifier Type: -
Identifier Source: org_study_id
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