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

NCT ID: NCT02546843

Last Updated: 2019-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2019-05-31

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

Conditions

Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Rocuronium

Intervention Type: DRUG

rocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction)

Specific Neuromuscular Blockade reversal

Intervention Type: DRUG

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

maintaining the depth of neuromuscular blockade - rocuronium

Intervention Type: DRUG

repeated boluses of rocuronium 0.3 mg/kg will be administered to maintain the muscular blockage - according to TOF 0, PTC 0-1

Group B

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.

Group Type: ACTIVE_COMPARATOR

Cisatracurium

Intervention Type: DRUG

cisatracurium 0.15mg/kg intravenously

Nonspecific Neuromuscular Blockade reversal

Intervention Type: DRUG

neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously

maintaining the depth of neuromuscular blockade - cisatracurium

Intervention Type: DRUG

repeated boluses of cisatracurium 0.03 mg/kg will be administered to maintain the muscular blockage - according to TOFmaintaining of muscular relaxation TOF 1

Interventions

Rocuronium

rocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction)

Intervention Type: DRUG

Cisatracurium

cisatracurium 0.15mg/kg intravenously

Intervention Type: DRUG

Nonspecific Neuromuscular Blockade reversal

neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously

Intervention Type: DRUG

Specific Neuromuscular Blockade reversal

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

Intervention Type: DRUG

maintaining the depth of neuromuscular blockade - rocuronium

repeated boluses of rocuronium 0.3 mg/kg will be administered to maintain the muscular blockage - according to TOF 0, PTC 0-1

Intervention Type: DRUG

maintaining the depth of neuromuscular blockade - cisatracurium

repeated boluses of cisatracurium 0.03 mg/kg will be administered to maintain the muscular blockage - according to TOFmaintaining of muscular relaxation TOF 1

Intervention Type: DRUG

Other Intervention Names

Esmeron; Nimbex; neuromuscular blockade; neuromuscular blockade

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KDCHOT FN Brno

UNKNOWN

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

MD,Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petr Štourač, MD, Ph.D

Role: STUDY_CHAIR

KDAR FN Brno

Locations

University Hospital Brno - FN Brno

Brno, Czech Republic, Czechia

Countries

Czechia

Other Identifiers

KDAR FN Brno

Identifier Type: -

Identifier Source: org_study_id