Effect of Deep BLock on Intraoperative Surgical Conditions
Condition: Prostate Hypertrophy; Renal Disease
MeSH terms: Prostatic Hyperplasia; Hypertrophy
Intervention: Surgical block (rocuronium; atracurium/mivacurium); Surgical block (rocuronium; atracurium/mivacurium)
Intervention description: The surgical block will be varied by either induction of a deep block (via rocuronium infusion) or a moderate/normal block (using atracurium/mivacurium infusion); A surgical block will be induced by infusion of either rocuronium (deep block) or atracurium/mivacurium (normal/moderate block)
Intervention MeSH terms: Rocuronium; Atracurium; Mivacurium
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: urology; muscle relaxation; laparoscopy; anesthesia; rocuronium

Summary:

      Rationale: A deep neuromuscular block is often associated with improved surgical conditions
      especially in laparoscopic surgery. However, a deep block comes at the expense of a variety
      of items that may conflict with the use of a deep surgical muscle blockade including a long
      recovery phase, the need for muscle reversal, postoperative ventilation, impaired
      postoperative breathing. With the introduction of Sugammadex there is now the possibility to
      reverse an even deep surgical block. This may overcome most if not all of the issues
      mentioned.

      Objective: To assess whether a deep neuromuscular block provides better surgical conditions
      than a moderately deep block as derived from a surgical rating score.

      Study design: Single center, double-blind randomized controlled trial. Study population: 24
      ASA I-III patients scheduled for laparoscopic renal (n=12, GROUP 1) or prostatic surgery
      (n=12, GROUP 2).

      Intervention: In both GROUP 1 and GROUP 2, 6 six patients will receive neuromuscular blockade
      according to current practice (atracurium (bolus) plus mivacurium (cont. infusion)) aimed at
      a moderately deep neuromuscular block (1-2 twitches in the Train of Four (TOF) monitor). The
      other six will receive a bolus plus continuous infusion with rocuronium aimed at a deep
      neuromuscular block (1-2 twitches post tetanic count (PTC)). All surgical procedures will be
      performed by one surgeon.

      Main study parameters/endpoints: To study the surgical conditions in patients undergoing
      laparoscopic renal or prostate surgery during deep versus less deep neuromuscular block as
      assessed by the surgical rating score.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Compared to current practice there will be no additional risk.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with renal or prostatic disease who are will undergo an elective
             laparoscopic renal surgical procedure or laparoscopic prostatectomy;

          -  ASA class I-III

          -  > 18 years of age;

          -  Ability to give oral and written informed consent

        Exclusion Criteria:

          -  Known or suspected neuromuscular disorders impairing neuromuscular function;

          -  Allergies to muscle relaxants, anesthetics or narcotics;

          -  A (family) history of malignant hyperthermia;

          -  Patients who have a contraindication for neostigmine administration;

          -  Women who are or may be pregnant or are currently breast feeding;

          -  Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output <
             0.5 ml/kg/h for at least 6 h. When available, other indices will be taken into account
             as well such as glomerular filtration rate < 60 ml/h and proteinuria (a ratio of 30 mg
             albumin to 1 g of creatinine).

          -  Previous retroperitoneal surgery at the site of the current surgery.

          -  Body mass index > 35 kg/m2