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

Neuromuscular Blockade Clinical Trial

— PedLapBlock  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546843
• Other study ID #: KDAR FN Brno
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: May 2019

Study information

• Verified date: May 2019
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Rocuronium
rocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction)
• Cisatracurium
cisatracurium 0.15mg/kg intravenously
• Nonspecific Neuromuscular Blockade reversal
neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously
• 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
• 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
• 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

Locations

Country	Name	City	State
Czechia	University Hospital Brno - FN Brno	Brno	Czech Republic

Sponsors (2)

Lead Sponsor	Collaborator
Brno University Hospital	KDCHOT FN Brno

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical scoring system	During the surgery the blinded surgeon will grade surgical conditions due to surgical scoring system	intraoperatively
Secondary	Number of adverse events	The adverse events will be monitored	intraoperatively