Neuromuscular BlockadePedLapBlockNCT02546843
Depth of Neuromuscular Blockade and the Perioperative Conditions in Laparoscopic Surgery in Pediatric Population
A study testing Rocuronium, Cisatracurium and Nonspecific Neuromuscular Blockade reversal in people with Neuromuscular Blockade, run by Brno University Hospital at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Rocuronium, Cisatracurium and Nonspecific Neuromuscular Blockade reversal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteCzechia
- Study dates
- Dec 2015to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- disagreement of the patient or his/her legal guardian
- serious comorbidities - renal or hepatic disorders
- ASA score ≥ 3
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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):
- 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
- Conditions
- Neuromuscular Blockade
- Being tested
- Rocuronium, Cisatracurium, Nonspecific Neuromuscular Blockade reversal, Specific Neuromuscular Blockade reversal, maintaining the depth of neuromuscular blockade - rocuronium
- Keywords
- rocuronium, sugammadex, pediatric anesthesia, cisatracurium, surgical conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Esmeron
rocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction)
CisatracuriumDrug
Also called Nimbex
cisatracurium 0.15mg/kg intravenously
Nonspecific Neuromuscular Blockade reversalDrug
neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously
Specific Neuromuscular Blockade reversalDrug
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 - rocuroniumDrug
Also called neuromuscular blockade
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 - cisatracuriumDrug
Also called neuromuscular blockade
repeated boluses of cisatracurium 0.03 mg/kg will be administered to maintain the muscular blockage - according to TOFmaintaining of muscular relaxation TOF 1
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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 Receives: Drug: Rocuronium; Drug: Specific Neuromuscular Blockade reversal; Drug: maintaining the depth of neuromuscular blockade - rocuronium |
| Group B | Active comparator | 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. Receives: Drug: Cisatracurium; Drug: Nonspecific Neuromuscular Blockade reversal; Drug: maintaining the depth of neuromuscular blockade - cisatracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical scoring system
During the surgery the blinded surgeon will grade surgical conditions due to surgical scoring system
Measured: intraoperatively
Secondary outcomes (1)
Number of adverse events
The adverse events will be monitored
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KDCHOT FN Brno
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, MD, Ph.D, Study chair, KDAR FN Brno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546843
- Sponsor's protocol ID
- KDAR FN Brno
- Acronym
- PedLapBlock
- Status last verified
- May 2019
- First submitted
- 5 Sep 2015
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02546843
- Acronym / sponsor ID
- PedLapBlock / KDAR FN Brno
- Conditions
- Neuromuscular Blockade
- Keywords
- rocuronium, sugammadex, pediatric anesthesia, cisatracurium, surgical conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- KDCHOT FN Brno
- Study start
- Dec 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Rocuronium, Drug: Specific Neuromuscular Blockade reversal, Drug: maintaining the depth of neuromuscular blockade - rocuroniumAfter 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 B | Active comparator | Drug: Cisatracurium, Drug: Nonspecific Neuromuscular Blockade reversal, Drug: maintaining the depth of neuromuscular blockade - cisatracuriumAfter 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- disagreement of the patient or his/her legal guardian
- serious comorbidities - renal or hepatic disorders
- ASA score ≥ 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RocuroniumAlso: Esmeronrocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction) | Drug | Group A |
| CisatracuriumAlso: Nimbexcisatracurium 0.15mg/kg intravenously | Drug | Group B |
| Nonspecific Neuromuscular Blockade reversalneostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously | Drug | Group B |
| Specific Neuromuscular Blockade reversalSugammadex 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 | Group A |
| maintaining the depth of neuromuscular blockade - rocuroniumAlso: neuromuscular blockaderepeated boluses of rocuronium 0.3 mg/kg will be administered to maintain the muscular blockage - according to TOF 0, PTC 0-1 | Drug | Group A |
| maintaining the depth of neuromuscular blockade - cisatracuriumAlso: neuromuscular blockaderepeated boluses of cisatracurium 0.03 mg/kg will be administered to maintain the muscular blockage - according to TOFmaintaining of muscular relaxation TOF 1 | Drug | Group B |
Primary outcome
Surgical scoring system
Time frame: intraoperatively
During the surgery the blinded surgeon will grade surgical conditions due to surgical scoring system
1 secondary outcome
Number of adverse events
Time frame: intraoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Štourač, MD, Ph.D study chair
KDAR FN Brno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium, Cisatracurium and Nonspecific Neuromuscular Blockade reversal in people with Neuromuscular Blockade, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical scoring system (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2019.