Depth of Neuromuscular Blockade and the Perioperative Conditions in Laparoscopic Surgery in Pediatric Population
Condition: Neuromuscular Blockade
MeSH terms: Disease
Study type: Interventional

Summary: 
      This randomized study prospectively evaluates our experience with administration of
      cisatracurium and rocuronium antagonized by sugammadex and evaluates the effects of various
      depths of neuromuscular blockage on providing optimal surgical conditions during laparoscopy
      with low-pressure capnoperitoneum.
    

Detailed description: 
      This randomized study prospectively evaluates our experience with administration of
      cisatracurium and rocuronium antagonized by sugammadex and evaluates the effects of various
      depths of neuromuscular blockage on providing optimal surgical conditions during laparoscopy
      with low-pressure capnoperitoneum.

      After meeting inclusion criteria the patients will be randomized - - use of opaque envelopes,
      randomization into groups A and B in an operating theatre, study blinded for the patient (or
      his/her legal guardian) and surgeon.

      Group A - muscle relaxation using rocuronium followed by sugammadex reversal (in a dose
      according to TOF - (train-of-four) 2-4mg/kg), depth of muscle relaxation TOF 0 PTC
      (post-tetanic count) 0-1 Group B - muscle relaxation using cisatracurium followed by
      decurarization (neostigmine 0.03 mg/kg and atropine 0.02 mg/kg)

      Anesthesia management:

        -  intravenous cannulation, preoxygenation, sufentanil 0.2 μg/kg intravenously, propofol
           2.0mg/kg and in Group A - rocuronium 0.6 mg/kg (1 mg/kg only in a case of a rapid
           sequence induction), in Group B - cisatracurium 0.15mg/kg

        -  orotracheal intubation, combined anesthesia using sevoflurane - MAC (minimal alveolar
           concentration) 1.0 with respect to the age of the patient

        -  ventilation: PCV (pressure-controlled ventilation ), PEEP (positive end-expiratory
           pressure) +5 cm H2O (aqua), normocapnia, FiO2 (fraction of inspired oxygen ) 1.0 until
           the intubation, afterwards 0.4 + AIR

        -  nasogastric tube placement

      Management of neuromuscular blockade:

      Group A - maintaining of deep muscular blockage - according to TOF 0, PTC 0-1, boluses of
      rocuronium 0.3 mg/kg are allowed Group B - maintaining of muscular relaxation TOF 1, boluses
      of cisatracurium 0.03 mg/kg are allowed Laparoscopy - capnoperitoneum pressure - 10 mmHg with
      a reduction to 8 mmHg if possible

      During the surgery the surgical conditions will be scored by using Surgical scoring system:
      (1-2 surgeons involved):

        1. Optimal conditions: there is a wide laparoscopic field, no movements or contractions

        2. Good conditions: there is a wide laparoscopic field with singular movements or muscle
           contractions

        3. Acceptable conditions: there is a wide laparoscopic field but muscle contractions and/or
           movements occur regularly. Additional neuromuscular blocking agent is required.

        4. Poor conditions: the same as in grade 3 and in addition, there is a hazard of tissue
           damage.

        5. Extremely poor conditions: the surgeon cannot work because of weak muscle relaxation,
           the patient is coughing. Additional neuromuscular blocking agent is essential.

      Recovery from anesthesia:

        -  extubation - TOF 0.9 - using sugammadex in Group A (2-4 mg/kg according to the depth of
           muscle relaxation) or decurarization in Group B (atropine 0.02 mg/kg and neostigmine
           0.03mg/kg)

        -  after standard 2-hour monitoring in the recovery room (heart rate, blood pressure, SpO2
           (oxygen saturation by pulse oximetry), level of consciousness, PONV), patients will be
           observed in the intensive care unit for at least 24 hours Statistical analysis:
           (provided by IBA MUNI - Institute of biostatistic and analyses by Masaryk University
           Brno, Czech Republic)

        -  demographic parameters - age, gender, type and duration of surgery

        -  induction to general anesthesia - time until intubation (recognition of the capnogram
           curve)

        -  ventilation - changes in the inspiratory pressure during capnoperitoneum, increase of
           EtCO2 (end-tidal CO2)

        -  capnoperitoneal pressure

        -  surgical scoring system
    

Intervention name(s): Rocuronium; Cisatracurium; Nonspecific Neuromuscular Blockade reversal; Specific Neuromuscular Blockade reversal; maintaining the depth of neuromuscular blockade - rocuronium; maintaining the depth of neuromuscular blockade - cisatracurium
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): rocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction); cisatracurium 0.15mg/kg intravenously; neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously; Sugammadex intravenously aimed to reverse the neuromuscular blockade.According to neuromuscular blockade monitoring: at TOF - (train-of-four) 2m g/kg, if TOF 0 and PTC(post-tetanic count) 0-1 4mg/kg of sugammadex will be administered; repeated boluses of rocuronium 0.3 mg/kg will be administered to maintain the muscular blockage - according to TOF 0, PTC 0-1; repeated boluses of cisatracurium 0.03 mg/kg will be administered to maintain the muscular blockage - according to TOFmaintaining of muscular relaxation TOF 1
Other intervention name(s): Esmeron; Nimbex; neuromuscular blockade; neuromuscular blockade
Intervention MeSH terms: Rocuronium; Atracurium; Cisatracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: rocuronium; sugammadex; pediatric anesthesia; cisatracurium; surgical conditions