Clinical trial NCT02546843: Depth of Neuromuscular Blockade and the Perioperative Conditions in Laparoscopic Surgery in Pediatric Population
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Blockade
Keywords: rocuronium
sugammadex
pediatric anesthesia
cisatracurium
surgical conditions
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: KDCHOT FN Brno
First posted: 2015-09-11
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Surgical scoring system
timeFrame: intraoperatively
Secondary outcomes:
measure: Number of adverse events
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno - FN Brno
state: Czech Republic
Study officials:
affiliation: KDAR FN Brno
name: Petr Štourač, MD, Ph.D
role: STUDY_CHAIR
References: