Deep Neuromuscular Block During General Anaesthesia in Robotic Surgery

Postoperative Recovery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420937
• Other study ID #: IGA_LF_2016_021
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2016
• Last updated: January 26, 2018
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: University Hospital Olomouc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Complication of Ventilation Therapy
• Observation of Neuromuscular Block
• Postoperative Recovery

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Czechia	Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc	Olomouc

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Olomouc	Palacky University

Country where clinical trial is conducted

Czechia, 

References & Publications (16)

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. — View Citation

Blobner M, Frick CG, Stäuble 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. — View 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. — View 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. — View Citation

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.000000000000009 — View 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. — View Citation

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. Review. — View Citation

Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13. Review. — View Citation

Gerges FJ, Kanazi GE, Jabbour-Khoury SI. Anesthesia for laparoscopy: a review. J Clin Anesth. 2006 Feb;18(1):67-78. Review. — View 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. Review. — View Citation

Kopman AF, Naguib M. Laparoscopic surgery and muscle relaxants: is deep block helpful? Anesth Analg. 2015 Jan;120(1):51-8. doi: 10.1213/ANE.0000000000000471. Review. — View Citation

Madsen MV, Gätke 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. — View 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. — View 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. — View Citation

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 Nov;119(5):1084-92. doi: 10.1213/ANE.0000000000000316. Erratum in: Anesth Analg. 2015 Apr;120(4):957. Dosage error in article text. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical conditions SRS	Describes the quality of surgical conditions as reported by surgeon	Perioperative period
Primary	Intraabdominal pressure IAP (mmHg)	Pressure in the abdominal cavity during capnoperitoneum	During surgery
Secondary	Operating theatre time (min)	Time from induction to anesthesia to the release from operating theatre	during anesthesia
Secondary	Post-operative recovery	Physiological functions, level of discomfort, subjective evaluation by the patient	post-operative period (1 week)