Postoperative Residual ParalysisNCT01503840
Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
A study testing sugammadex and Sodium chloride solution in people with Postoperative Residual Paralysis, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial summary
Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Residual Paralysis
- What is being tested?
- sugammadex and Sodium chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2011to Jul 2012
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing major abdominal surgery
- age between 18 and 70 years
- ASA class 1 or 2
- patients scheduled for blended anesthesia (epidural + general anesthesia)
- patients capable to perform pulmonary function tests (preoperative values of MIP, MEP, FEV1% and FEV1/FVC in normal ranges).
Who cannot join
- known or suspected respiratory, cardiovascular or neuromuscular disease
- renal or hepatic failure
- known or suspected allergies to drugs used in the study
- risk for malignant hyperthermia
- pregnancy
- diagnosed depressive disorder
Trial locations and contacts
1 site in 1 country.
About this study
Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered the gold-standard to avoid PORC (post operative residual curarization).
This clinical trial is conducted to verify the reliability of accelerometer-based neuromuscular monitoring in order to exclude postoperative residual paralysis which is not highlighted by this instrument at a TOF-ratio=100%.
The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although the monitoring device shows a complete decurarization; patients treated with sugammadex should not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.
Read the detailed description
From the beginning of the surgery to the time of extubation neuromuscular block is monitored with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.
Patients will perform pulmonary function tests (PFTs):
- the day ahead of surgery (for elegibility and training)
- 60 minutes before surgery
- 10 minutes after extubation
- 5 minutes after sugammadex or placebo administration
- 20 minutes after sugammadex or placebo administration.
The following parameters will be evaluated and compared between the 2 groups:
- Maximal Inspiratory Pressure (MIP)
- Maximal Expiratory Pressure (MEP)
- Forced Expiratory Volume in the first Second (FEV1)
- Forced Vital Capacity (FVC)
- Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50)
- PaO2, PaCO2, pH
- heart rate, blood pressure and respiratory rate
Changes of pulmonary tests performed before and after sugammadex or placebo will be compared between study groups.
- Conditions
- Postoperative Residual Paralysis
- Being tested
- sugammadex, Sodium chloride solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadexDrug
Also called Bridion
sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg)
Sodium chloride solutionDrug
Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Active comparator | Not described Receives: Drug: sugammadex |
| Sodium chloride solution | Placebo comparator | Not described Receives: Drug: Sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Measured: 10 minutes after surgery and 5 minutes later
Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Measured: 10 minutes after surgery and 5 minutes later
Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Measured: 10 minutes after surgery and 5 minutes later
Forced Vital Capacity (FVC) changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Measured: 10 minutes after surgery and 5 minutes later
Secondary outcomes (3)
Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Measured: 10 minutes after surgery and 5 minutes later
Hemogasanalysis parameters changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Measured: 10 minutes after surgery and 5 minutes later
Swallow ability changes after placebo or sugammadex
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Measured: 10 minutes after surgery and 5 minutes later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Residual ParalysisStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 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, Study director, Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503840
- Sponsor's protocol ID
- INT-66/11
- Status last verified
- Apr 2014
- First submitted
- 29 Dec 2011
- Last updated
- 22 Apr 2014
- Results posted
- No
Publications
Piccioni F, Mariani L, Bogno L, Rivetti I, Tramontano GT, Carbonara M, Ammatuna M, Langer M. An acceleromyographic train-of-four ratio of 1.0 reliably excludes respiratory muscle weakness after major abdominal surgery: a randomized double-blind study. Can J Anaesth. 2014 Jul;61(7):641-9. doi: 10.1007/s12630-014-0160-7. Epub 2014 Apr 17.
PubMed 24740312
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
- ClinicalTrials.gov ID
- NCT01503840
- Acronym / sponsor ID
- INT-66/11
- Conditions
- Postoperative Residual Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 4 Jan 2012 (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.
Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered the gold-standard to avoid PORC (post operative residual curarization).
This clinical trial is conducted to verify the reliability of accelerometer-based neuromuscular monitoring in order to exclude postoperative residual paralysis which is not highlighted by this instrument at a TOF-ratio=100%.
The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although the monitoring device shows a complete decurarization; patients treated with sugammadex should not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.
Detailed description
From the beginning of the surgery to the time of extubation neuromuscular block is monitored with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.
Patients will perform pulmonary function tests (PFTs):
- the day ahead of surgery (for elegibility and training)
- 60 minutes before surgery
- 10 minutes after extubation
- 5 minutes after sugammadex or placebo administration
- 20 minutes after sugammadex or placebo administration.
The following parameters will be evaluated and compared between the 2 groups:
- Maximal Inspiratory Pressure (MIP)
- Maximal Expiratory Pressure (MEP)
- Forced Expiratory Volume in the first Second (FEV1)
- Forced Vital Capacity (FVC)
- Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50)
- PaO2, PaCO2, pH
- heart rate, blood pressure and respiratory rate
Changes of pulmonary tests performed before and after sugammadex or placebo will be compared between study groups.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Active comparator | Drug: sugammadex |
| Sodium chloride solution | Placebo comparator | Drug: Sodium chloride solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients undergoing major abdominal surgery
- age between 18 and 70 years
- ASA class 1 or 2
- patients scheduled for blended anesthesia (epidural + general anesthesia)
- patients capable to perform pulmonary function tests (preoperative values of MIP, MEP, FEV1% and FEV1/FVC in normal ranges).
Key exclusion criteria (6 listed)
- known or suspected respiratory, cardiovascular or neuromuscular disease
- renal or hepatic failure
- known or suspected allergies to drugs used in the study
- risk for malignant hyperthermia
- pregnancy
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 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg) | Drug | Sugammadex |
| Sodium chloride solutionSodium chloride solution 0,9% dosage: 0,1 ml/kg i.v. | Drug | Sodium chloride solution |
Primary outcome
Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
Time frame: 10 minutes after surgery and 5 minutes later
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex
Time frame: 10 minutes after surgery and 5 minutes later
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex
Time frame: 10 minutes after surgery and 5 minutes later
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
Forced Vital Capacity (FVC) changes after placebo or sugammadex
Time frame: 10 minutes after surgery and 5 minutes later
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
3 secondary outcomes
Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex
Time frame: 10 minutes after surgery and 5 minutes later
Hemogasanalysis parameters changes after placebo or sugammadex
Time frame: 10 minutes after surgery and 5 minutes later
Swallow ability changes after placebo or sugammadex
Time frame: 10 minutes after surgery and 5 minutes later
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 22 Apr 2014.
- Results publication: PubMed 24740312Piccioni F, Mariani L, Bogno L, Rivetti I, Tramontano GT, Carbonara M, Ammatuna M, Langer M. An acceleromyographic train-of-four ratio of 1.0 reliably excludes respiratory muscle weakness after major abdominal surgery: a randomized double-blind study. Can J Anaesth. 2014 Jul;61(7):641-9. doi: 10.1007/s12630-014-0160-7. Epub 2014 Apr 17.
Related trials for Postoperative Residual Paralysis
Active, not recruitingObservational study
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Residual Paralysis, Post Anesthesia, Postoperative Complications
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 study director
Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sugammadex and Sodium chloride solution in people with Postoperative Residual Paralysis, 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 5 inclusion and 6 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 22 Apr 2014. 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. Some participants in this study may receive a placebo. 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?
Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex (time frame: 10 minutes after surgery and 5 minutes later). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01503840, which also lists 1 linked publication.
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 22 Apr 2014.