Neuromuscular BlockadePhase 4DATANCT02256280
A Randomized Double Blind Controlled Trial Comparing Sugammadex and Neostigmine After Thoracic Anesthesia
A Phase 4 study testing Sugammadex and Neostigmine in people with Neuromuscular Blockade, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
At the end of anesthesia it's important to avoid residual neuromuscular block to ensure adequate respiratory function preventing postoperative pulmonary complications. This trial compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine) after thoracic anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Sugammadex and Neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Mar 2020
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects scheduled for pulmonary resection, lobectomy, pneumonectomy, bullectomy, pleurodesis
- Age 18-70 years
- American Society of Anesthesiologists (ASA) class 1, 2, 3
- Body mass Index (BMI) = 18-30 kg/m2
Who cannot join
- Subjects scheduled for esophagectomy, thoracectomy, vascular resection
- Chronic Obstructive Pulmonary Disease (COPD) Gold class III e IV, respiratory infection, asthma
- Preoperative Forced Expiratory Volume in 1 second (FEV1) < 60% of predicted, Forced Expiratory Volume in 1 second/Forced Vital Capacity ratio (FEV1/FVC) <70%
- Preoperative Diffusion Lung capacity for carbon monoxide/Alveolar Volume ratio (DLCO/VA) < 60% of predicted
- Preoperative oxygen saturation (SpO2) <92% or Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (PaO2/FiO2) ratio <300
- Cardiovascular disease with Metabolic Equivalent of Tasks (METS) score less than 4
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- Neuromuscular disorder
- Kidney failure defined as Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1,73 m2
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decurarization After Thoracic Anesthesia - A Prospective Multicenter Double-blind Randomized Trial Comparing Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia
At the end of anesthesia it's important to avoid residual neuromuscular block to ensure adequate respiratory function preventing postoperative pulmonary complications. This trial compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine) after thoracic anesthesia. The trial main objective is to demonstrate that sugammadex is faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is to verify if there is a difference between sugammadex and neostigmine as regards adverse events after extubation and in the postoperative period (until the 30th day after surgery).
Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value during an accelerometric train-of-four stimulation.
Read the detailed description
Patients undergoing thoracic surgery will receive rocuronium as neuromuscular blocking agent. Anesthesia and neuromuscular blockade will be managed freely until the end of surgery. Then patients will be randomized to receive intravenous sugammadex or neostigmine/atropine as follows:
Sugammadex group:
- If Post tetanic count (PTC)=1-15: sugammadex 4 mg/kg
- If at least 1 twitch at the Train-of-four stimulation: sugammadex 2 mg/kg
Neostigmine group:
- If PTC=1-15: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
- If at least 1 twitch at the Train-of-four (TOF) stimulation: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
- Conditions
- Neuromuscular Blockade
- Being tested
- Sugammadex, Neostigmine
- Keywords
- Neuromuscular blockade, Thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
Sugammadex will be diluted in a saline water solution in a 10 mL syringe.
Administration will be according to the neuromuscular blockade:
- If Post tetanic count = 1-15: 4 mg/kg
- If at least 1 twitch at the Train-of-four stimulation: 2 mg/kg
NeostigmineDrug
Also called Intrastigmina
Neostigmine will be diluted with atropine in a saline water solution in a 10 mL syringe.
Administration will be according to the neuromuscular blockade:
- If Post tetanic count = 1-15: 0.07 mg/kg
- If at least 1 twitch at the Train-of-four stimulation: 0.05 mg/kg Atropine will be administered at a 0.02 mg/kg dosage.
| Study group | Role | What they receive |
|---|---|---|
| S Group | Experimental | Sugammadex 2 or 4 mg/kg iv once at the end of surgery Receives: Drug: Sugammadex |
| N Group | Active comparator | Neostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) iv once at the end of surgery Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9
Time from reversal administration to at least 3 TOF-ratio value = or > 0.9
Measured: At the end of general anesthesia
Secondary outcomes (6)
Mean time from reversal administration to TOF-ratio = 1.0
Time from reversal administration to at least 3 TOF-ratio value = or > 1.0
Measured: At the end of general anesthesia
Mean time from reversal administration to extubation
Time from reversal administration to tracheal extubation
Measured: At the end of anesthesia
Muscular weakness incidence
Measured by the tongue depressor test
Measured: In the first 60 minutes after extubation
Hypoxemia or hypercapnia incidence
Hypoxemia defined as Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen ratio (PaO2/FiO2) < 300. Hypercapnia defined as Partial pressure of carbon dioxide in arterial blood (PaCO2) > 45 mmHg.
Measured: In the first 60 minutes after extubation
Adverse events incidence
Incidence of nausea or vomit, abdominal pain, cardiac arrhythmias, hypotension coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology
Measured: In the first 60 minutes after extubation
Postoperative complications incidence
Incidence of medical and surgical complications coded according to the MedDRA terminology
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionMar 2020
- Study completionMar 2020
Why it stopped: Low recruiting rate due to not activation of some collaborator centers
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.
- More trials run by Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Piccioni, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Investigators
- Federico Piccioni, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256280
- Sponsor's protocol ID
- INT-91/14
- Other IDs
- 2014-002021-35, 2014
- Acronym
- DATA
- Status last verified
- Jun 2021
- First submitted
- 24 Sep 2014
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decurarization After Thoracic Anesthesia - A Prospective Multicenter Double-blind Randomized Trial Comparing Sugammadex vs Neostigmine Reversal After Thoracic Anesthesia
- ClinicalTrials.gov ID
- NCT02256280
- Acronym / sponsor ID
- DATA / INT-91/14
- Conditions
- Neuromuscular Blockade
- Keywords
- Neuromuscular blockade, Thoracic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruiting rate due to not activation of some collaborator centers
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 3 Oct 2014 (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.
At the end of anesthesia it's important to avoid residual neuromuscular block to ensure adequate respiratory function preventing postoperative pulmonary complications. This trial compares the neuromuscular block reversal with different drugs (sugammadex vs neostigmine) after thoracic anesthesia. The trial main objective is to demonstrate that sugammadex is faster than neostigmine to reach a Train-of-four-Ratio (TOF-ratio) of 0.9 after thoracic anesthesia, demonstrating that sugammadex allows a faster extubation. Other main purpose is to verify if there is a difference between sugammadex and neostigmine as regards adverse events after extubation and in the postoperative period (until the 30th day after surgery).
Note: TOF-ratio is defined as the ratio of the fourth muscular twitch/first twitch value during an accelerometric train-of-four stimulation.
Detailed description
Patients undergoing thoracic surgery will receive rocuronium as neuromuscular blocking agent. Anesthesia and neuromuscular blockade will be managed freely until the end of surgery. Then patients will be randomized to receive intravenous sugammadex or neostigmine/atropine as follows:
Sugammadex group:
- If Post tetanic count (PTC)=1-15: sugammadex 4 mg/kg
- If at least 1 twitch at the Train-of-four stimulation: sugammadex 2 mg/kg
Neostigmine group:
- If PTC=1-15: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
- If at least 1 twitch at the Train-of-four (TOF) stimulation: neostigmine 0.07 mg/kg + atropine 0.02 mg/kg
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S Group | Experimental | Drug: SugammadexSugammadex 2 or 4 mg/kg iv once at the end of surgery |
| N Group | Active comparator | Drug: NeostigmineNeostigmine 0.05 or 0.07 mg/kg (+ atropine 0.02 mg/kg) iv once at the end of surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects scheduled for pulmonary resection, lobectomy, pneumonectomy, bullectomy, pleurodesis
- Age 18-70 years
- American Society of Anesthesiologists (ASA) class 1, 2, 3
- Body mass Index (BMI) = 18-30 kg/m2
Key exclusion criteria (9 listed)
- Subjects scheduled for esophagectomy, thoracectomy, vascular resection
- Chronic Obstructive Pulmonary Disease (COPD) Gold class III e IV, respiratory infection, asthma
- Preoperative Forced Expiratory Volume in 1 second (FEV1) < 60% of predicted, Forced Expiratory Volume in 1 second/Forced Vital Capacity ratio (FEV1/FVC) <70%
- Preoperative Diffusion Lung capacity for carbon monoxide/Alveolar Volume ratio (DLCO/VA) < 60% of predicted
- Preoperative oxygen saturation (SpO2) <92% or Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen (PaO2/FiO2) ratio <300
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 |
|---|---|---|
| SugammadexAlso: BridionSugammadex will be diluted in a saline water solution in a 10 mL syringe. Administration will be according to the neuromuscular blockade: * If Post tetanic count = 1-15: 4 mg/kg * If at least 1 twitch at the Train-of-four stimulation: 2 mg/kg | Drug | S Group |
| NeostigmineAlso: IntrastigminaNeostigmine will be diluted with atropine in a saline water solution in a 10 mL syringe. Administration will be according to the neuromuscular blockade: * If Post tetanic count = 1-15: 0.07 mg/kg * If at least 1 twitch at the Train-of-four stimulation: 0.05 mg/kg Atropine will be administered at a 0.02 mg/kg dosage. | Drug | N Group |
Primary outcome
Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9
Time frame: At the end of general anesthesia
Time from reversal administration to at least 3 TOF-ratio value = or > 0.9
6 secondary outcomes
Mean time from reversal administration to TOF-ratio = 1.0
Time frame: At the end of general anesthesia
Mean time from reversal administration to extubation
Time frame: At the end of anesthesia
Muscular weakness incidence
Time frame: In the first 60 minutes after extubation
Hypoxemia or hypercapnia incidence
Time frame: In the first 60 minutes after extubation
Adverse events incidence
Time frame: In the first 60 minutes after extubation
Postoperative complications incidence
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Results and safety
The study was stopped early (reason given: Low recruiting rate due to not activation of some collaborator centers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
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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.
Federico Piccioni, MD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex and Neostigmine in people with Neuromuscular Blockade, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
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 9 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: stopped early, as of the sponsor's last update on 16 Jun 2021. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruiting rate due to not activation of some collaborator centers). Results are not available in the source record.
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?
Mean time from reversal administration to Train-of-four-ratio (TOF-ratio) = 0.9 (time frame: At the end of general anesthesia). 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 16 Jun 2021.