Deep Neuromuscular Blockade During Robotic Radical Prostatectomy

NCT02513693 | Unknown Phase 4

• 1 other identifier: IGA_LF_2015_012
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Basic requirement for safe performance of the robotic intra-abdominal surgery is a calm and clear surgical field after the introduction of a capnoperitoneum. That can be enabled by a neuromuscular blockade. Provision of standard neuromuscular blockade is a compromise between optimal surgical conditions (sufficiently deep block) and capability to antagonize the block rapidly at the end of the surgery. With rocuronium, it is possible to maintain deep neuromuscular blockade safely until the very end of the surgery, and unlike with spontaneous recovery or reversal of the block with neostigmine, administration of sugammadex at the end of the surgery will enable quick and consistent reversal of the block. Project is focused on comparison of the parameters of deep and standard neuromuscular blockade - surgical conditions (primary endpoint), quality of recovery and turnover time (secondary endpoints).

Conditions

Neuromuscular Blockade

Keywords

Anesthesia; Rocuronium; Sugammadex; Neostigmine; TOF; Radical Prostatectomy; Robotic Surgery; Accelerometry

Outcome Measures

Primary Outcomes (1)

• Surgical condition

  Surgical rating score (SRS) - surgical condition will be evaluated by surgeon every 15 minutes on predefined five point scale (excellent - above average - average - below average - poor). For each patient, the final score will be the average of all 15 min SRS values.

  Every 15 minutes during surgery until final suture

Secondary Outcomes (2)

• Quality of recovery

  2 months

• "Ready to leave operating room (OR)" time

  Period of patient's presence at OR

Study Arms (2)

Standard Neuromuscular Blockade

EXPERIMENTAL

Drug: rocuronium + neostigmine 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. 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.

Drug: Standard neuromuscular blockade

Deep Neuromuscular Blockade

EXPERIMENTAL

Drug: rocuronium + sugammadex 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. 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.

Drug: Deep neuromuscular blockade

Interventions

Standard neuromuscular blockade DRUG

Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.

Also known as: Rocuronium + neostigmine

Standard Neuromuscular Blockade

Deep neuromuscular blockade DRUG

Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.

Also known as: Rocuronium + sugammadex

Deep Neuromuscular Blockade

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Age 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)

Sponsors & Collaborators

• Palacky University: lead
• University Hospital Olomouc: collaborator
• Masaryk Hospital Usti nad Labem: collaborator

Study Sites (2)

Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc

Olomouc, 775 20, Czechia

RECRUITING

Dept. of Anesthesiology, Perioperative Medicine and Intensive Care, J. E. Purkinje University, Masaryk Hospital

Ústí nad Labem, 401 13, Czechia

RECRUITING

Related Publications (14)

• Lindekaer AL, Halvor Springborg H, Istre O. Deep neuromuscular blockade leads to a larger intraabdominal volume during laparoscopy. J Vis Exp. 2013 Jun 25;(76):50045. doi: 10.3791/50045.

  PMID: 23851450 RESULT

• Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gatke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579.

  PMID: 23461992 RESULT

• Boon M, Martini CH, Aarts LP, Bevers RF, Dahan A. Effect of variations in depth of neuromuscular blockade on rating of surgical conditions by surgeon and anesthesiologist in patients undergoing laparoscopic renal or prostatic surgery (BLISS trial): study protocol for a randomized controlled trial. Trials. 2013 Mar 1;14:63. doi: 10.1186/1745-6215-14-63.

  PMID: 23452344 RESULT

• Ding L, Zhang H, Mi W, Sun L, Zhang X, Ma X, Li H. [Effects of carbon dioxide pneumoperitoneum and steep Trendelenburg positioning on cerebral blood backflow during robotic radical prostatectomy]. Nan Fang Yi Ke Da Xue Xue Bao. 2015 May;35(5):712-5. Chinese.

  PMID: 26018268 RESULT

• Ding L, Zhang H, Mi W, He Y, Zhang X, Ma X, Li H. [Effects of dexmedetomidine on recovery period of anesthesia and postoperative cognitive function after robot-assisted laparoscopicradical prostatectomy in the elderly people]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2015 Feb;40(2):129-35. doi: 10.11817/j.issn.1672-7347.2015.02.003. Chinese.

  PMID: 25769330 RESULT

• Dogra PN, Saini AK, Singh P, Bora G, Nayak B. Extraperitoneal robot-assisted laparoscopic radical prostatectomy: Initial experience. Urol Ann. 2014 Apr;6(2):130-4. doi: 10.4103/0974-7796.130555.

  PMID: 24833824 RESULT

• 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.

  PMID: 25625254 RESULT

• Donati F, Brull SJ. More muscle relaxation does not necessarily mean better surgeons or "the problem of muscle relaxation in surgery". Anesth Analg. 2014 Nov;119(5):1019-21. doi: 10.1213/ANE.0000000000000429. No abstract available.

  PMID: 25329018 RESULT

• 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 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.

  PMID: 24240315 RESULT

• 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.

  PMID: 24977638 RESULT

• 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.

  PMID: 24809482 RESULT

• Vijayaraghavan N, Sistla SC, Kundra P, Ananthanarayan PH, Karthikeyan VS, Ali SM, Sasi SP, Vikram K. Comparison of standard-pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy: a double blinded randomized controlled study. Surg Laparosc Endosc Percutan Tech. 2014 Apr;24(2):127-33. doi: 10.1097/SLE.0b013e3182937980.

  PMID: 24686347 RESULT

• Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.

  PMID: 24639018 RESULT

• Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.

  PMID: 20601860 RESULT

MeSH Terms

Interventions

Rocuronium; Neostigmine; Sugammadex

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Milan Adamus, MD,PhD,MBA

  Department of Anesthesiology and Intensive Care Medicine Palacky University Olomouc Faculty of Medicine and Dentistry

  STUDY DIRECTOR

• Vladimir Cerny, MD,PhD,FCCM

  J. E. Purkinje University, Masaryk Hospital, Usti nad Labem, Czech Republic, Dept. of Anesthesiology, Perioperative Medicine and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milan Adamus, MD,PhD,MBA

CONTACT

+420588442705; milan.adamus@seznam.cz

Lenka Doubravská, MD

CONTACT

+420588445979; lenadoub@seznam.cz

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Milan Adamus, MD, PhD, MBA

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 3, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 3, 2015

Record last verified: 2015-07

Locations

CZ (2)