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

May 17, 2019 updated by: Petr Štourač, MD, Brno University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Brno, Czech Republic, Czechia, 62500
        • University Hospital Brno - FN Brno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Rocuronium
rocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction)
Other Names:
  • Esmeron
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
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
Other Names:
  • neuromuscular blockade
Active Comparator: 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.
Drug: Cisatracurium
cisatracurium 0.15mg/kg intravenously
Other Names:
  • Nimbex
Drug: Nonspecific Neuromuscular Blockade reversal
neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously
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
Other Names:
  • neuromuscular blockade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical scoring system
Time Frame: intraoperatively
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
Time Frame: intraoperatively
The adverse events will be monitored
intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brno University Hospital

Collaborators

KDCHOT FN Brno

Investigators

  • Study Chair: Petr Štourač, MD, Ph.D, KDAR FN Brno

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

September 5, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDAR FN Brno

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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