Depth of Neuromuscular Blockade and the Perioperative Conditions in Laparoscopic Surgery in Pediatric Population

Study Overview
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Brief Summary
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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
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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): Optimal conditions: there is a wide laparoscopic field, no movements or contractions Good conditions: there is a wide laparoscopic field with singular movements or muscle contractions Acceptable conditions: there is a wide laparoscopic field but muscle contractions and/or movements occur regularly. Additional neuromuscular blocking agent is required. Poor conditions: the same as in grade 3 and in addition, there is a hazard of tissue damage. 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

Official Title
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Deep Neuromuscular Blockade During Laparoscopic Surgery in Pediatric Patient and the Impact of the Depth of the Blockade on the Surgery Conditions, Perioperative Complications and Surgeon Satisfaction

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: Rocuronium
* Drug: Cisatracurium
* Drug: Nonspecific Neuromuscular Blockade reversal
* Drug: Specific Neuromuscular Blockade reversal
* Drug: maintaining the depth of neuromuscular blockade - rocuronium
* Drug: maintaining the depth of neuromuscular blockade - cisatracurium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pediatric patients aged 2 to 17 years (+ 364 days) eligible for laparoscopy (diagnostic laparoscopy, appendectomy, cholecystectomy, nephrectomy, splenectomy, tumor biopsy, varicocele correction, testicular retention) fasting of at least 6 hours ASA (American Society of Anesthesiology score) score 1 or 2 signed informed consent of the legal guardian of the patient Exclusion Criteria: disagreement of the patient or his/her legal guardian serious comorbidities - renal or hepatic disorders ASA score ≥ 3

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>After anesthesia induction: intravenous cannulation, preoxygenation, sufentanil 0.2 μg/kg intravenously, propofol 2.0mg/kg the neuromuscular blockade will be induced with rocuronium 0.6 mg/kg (1 mg/kg only in a case of a rapid sequence induction). maintaining the depth of neuromuscular blockade - rocuronium: the appropriate depth of the block will be maintained with repeated boluses of rocuronium 0.3 mg/kg according to TOF 0, PTC 0-1. Specific Neuromuscular Blockade reversal will be performed with Sugammadex intravenously. The proper dosage of sugammadex will depend on the depth of the blockade:at TOF -1-2 (train-of-four) 2m g/kg, if TOF 0 and PTC(post-tetanic count) 0-1 4mg/kg of sugammadex will be administered | Drug: Rocuronium<br>* rocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction)<br>* Other names: Esmeron;Drug: Specific Neuromuscular Blockade reversal<br>* 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<br>Drug: maintaining the depth of neuromuscular blockade - rocuronium<br>* repeated boluses of rocuronium 0.3 mg/kg will be administered to maintain the muscular blockage - according to TOF 0, PTC 0-1<br>* Other names: neuromuscular blockade;|
| Active Comparator: Group B<br>After anesthesia induction: intravenous cannulation, preoxygenation, sufentanil 0.2 μg/kg intravenously, propofol 2.0mg/kg the neuromuscular blockade will be induced with cisatracurium 0.15mg/kg intravenously. Maintaining the depth of neuromuscular blockade - cisatracurium:the appropriate depth of the block will be maintained with repeated boluses of cisatracurium 0.03 mg/kg - according to TOF maintaining of muscular relaxation TOF 1. Nonspecific Neuromuscular Blockade reversal will be performed with neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously, the reversal will be applicated in case of TOF 1 or higher. | Drug: Cisatracurium<br>* cisatracurium 0.15mg/kg intravenously<br>* Other names: Nimbex;Drug: Nonspecific Neuromuscular Blockade reversal<br>* neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously<br>Drug: maintaining the depth of neuromuscular blockade - cisatracurium<br>* repeated boluses of cisatracurium 0.03 mg/kg will be administered to maintain the muscular blockage - according to TOFmaintaining of muscular relaxation TOF 1<br>* Other names: neuromuscular blockade;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical scoring system | During the surgery the blinded surgeon will grade surgical conditions due to surgical scoring system | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | The adverse events will be monitored | intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rocuronium, sugammadex, pediatric anesthesia, cisatracurium, surgical conditions