Postoperative ComplicationsNCT02673853
Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion
An observational study of Postoperative Complications, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study aims to establish the incidence of residual paralysis in patients following administration of a mini- dose of atracurium (less than ED95 i.e. <0.23mg/kg or <15 mg in most patients) during supraglottic airway insertion and correlate it with the duration of time from drug administration to arrival at PACU. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Postoperative Complications
- How many people
- 337 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2016to 16 Mar 2018
- Phase
- Observational
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be picked from all patients who are going surgery at National University Hospital (NUH) during the period of data collection, and who are receiving supraglottic airway for their procedure. They must fulfil the inclusion and exclusion criteria.
Who may be able to join
- Adults above 21 years old
- Received either a mini-dose of atracurium or full dose of atracurium during the placement of the supraglottic airway
- Did not receive any neuromuscular reversal agent at any point of the operation.
Who cannot join
- Patients with underlying neuromuscular disease
- Patients who received pre-operative medication that may affect neuromuscular transmission
- Patients who required additional doses of neuromuscular blockade at any point of the operation
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to establish the incidence of residual paralysis in patients following administration of a mini- dose of atracurium (less than ED95 i.e. <0.23mg/kg or <15 mg in most patients) during supraglottic airway insertion and correlate it with the duration of time from drug administration to arrival at PACU. The secondary aim is to compare the incidence of residual paralysis in patients who receive full doses of atracurium (per body weight) with those who receive mini-doses.
Read the detailed description
Post-operative residual paralysis may be defined as the incomplete recovery of muscle function following intra-operative administration of neuromuscular blockers (NMBs). This condition is associated with many negative patient outcomes such as: increased risk of aspiration; upper airway obstruction; and delayed Post-Anaesthetic Care Unit (PACU) discharge, amongst others. Despite the increasing use of shorter acting agents, the prevalence of residual paralysis in the PACU remains high at 20-50%. NMBs are commonly used to facilitate endotracheal intubation and insertion of the supraglottic airway by obtunding airway reflexes. Given the increasing use of mini-dose NMBs without post-operative reversal in clinical practice, there is a need to evaluate the incidence of residual paralysis in the patient population who have received mini-dose atracurium during the supraglottic airway insertion.
- Conditions
- Postoperative Complications
- Keywords
- Supraglottic airway, Mini-dose atracurium, Postoperative residual paralysis
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Post operative residual paralysis as measured by Train of Four (TOF) Ratio of < 0.9
Measuring the extent of operative paralysis using established methods such as the train of four (TOF) with ratio of <0.9 indicating inadequate recovery, Double burst stimulation, acceleromyography, five second head lift and tongue depressor test. The relevant data about the patient's condition will be collected and filled up in the data collection form.
Measured: Through study completion, up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion8 Mar 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lian Kah Ti, MBBS, MMed, Principal investigator, National University Health System (NUHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673853
- Sponsor's protocol ID
- 2015/00055
- Other IDs
- 2015
- Status last verified
- Aug 2018
- First submitted
- 4 Jan 2016
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Plaud B. Neuromuscular monitoring, residual blockade, and reversal: time for re-evaluation of our clinical practice. Can J Anaesth. 2013 Jul;60(7):634-40. doi: 10.1007/s12630-013-9952-4. Epub 2013 May 10. No abstract available.
PubMed 23661296Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.
PubMed 25902322Donati F. Residual paralysis: a real problem or did we invent a new disease? Can J Anaesth. 2013 Jul;60(7):714-29. doi: 10.1007/s12630-013-9932-8. Epub 2013 Apr 27.
PubMed 23625545
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion
- ClinicalTrials.gov ID
- NCT02673853
- Acronym / sponsor ID
- 2015/00055
- Conditions
- Postoperative Complications
- Keywords
- Supraglottic airway, Mini-dose atracurium, Postoperative residual paralysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 4 Feb 2016 (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 study aims to establish the incidence of residual paralysis in patients following administration of a mini- dose of atracurium (less than ED95 i.e. <0.23mg/kg or <15 mg in most patients) during supraglottic airway insertion and correlate it with the duration of time from drug administration to arrival at PACU. The secondary aim is to compare the incidence of residual paralysis in patients who receive full doses of atracurium (per body weight) with those who receive mini-doses.
Detailed description
Post-operative residual paralysis may be defined as the incomplete recovery of muscle function following intra-operative administration of neuromuscular blockers (NMBs). This condition is associated with many negative patient outcomes such as: increased risk of aspiration; upper airway obstruction; and delayed Post-Anaesthetic Care Unit (PACU) discharge, amongst others. Despite the increasing use of shorter acting agents, the prevalence of residual paralysis in the PACU remains high at 20-50%. NMBs are commonly used to facilitate endotracheal intubation and insertion of the supraglottic airway by obtunding airway reflexes. Given the increasing use of mini-dose NMBs without post-operative reversal in clinical practice, there is a need to evaluate the incidence of residual paralysis in the patient population who have received mini-dose atracurium during the supraglottic airway insertion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be picked from all patients who are going surgery at National University Hospital (NUH) during the period of data collection, and who are receiving supraglottic airway for their procedure. They must fulfil the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Adults above 21 years old
- Received either a mini-dose of atracurium or full dose of atracurium during the placement of the supraglottic airway
- Did not receive any neuromuscular reversal agent at any point of the operation.
Key exclusion criteria (3 listed)
- Patients with underlying neuromuscular disease
- Patients who received pre-operative medication that may affect neuromuscular transmission
- Patients who required additional doses of neuromuscular blockade at any point of the operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with Post operative residual paralysis as measured by Train of Four (TOF) Ratio of < 0.9
Time frame: Through study completion, up to 4 months
Measuring the extent of operative paralysis using established methods such as the train of four (TOF) with ratio of <0.9 indicating inadequate recovery, Double burst stimulation, acceleromyography, five second head lift and tongue depressor test. The relevant data about the patient's condition will be collected and filled up in the data collection form.
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 27 Aug 2018.
- Background: PubMed 23661296Plaud B. Neuromuscular monitoring, residual blockade, and reversal: time for re-evaluation of our clinical practice. Can J Anaesth. 2013 Jul;60(7):634-40. doi: 10.1007/s12630-013-9952-4. Epub 2013 May 10. No abstract available.
- Background: PubMed 25902322Fortier LP, McKeen D, Turner K, de Medicis E, Warriner B, Jones PM, Chaput A, Pouliot JF, Galarneau A. The RECITE Study: A Canadian Prospective, Multicenter Study of the Incidence and Severity of Residual Neuromuscular Blockade. Anesth Analg. 2015 Aug;121(2):366-72. doi: 10.1213/ANE.0000000000000757.
- Background: PubMed 23625545Donati F. Residual paralysis: a real problem or did we invent a new disease? Can J Anaesth. 2013 Jul;60(7):714-29. doi: 10.1007/s12630-013-9932-8. Epub 2013 Apr 27.
- Individual participant dataSharing planned: No
Related trials for Postoperative Complications
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Lian Kah Ti, MBBS, MMed principal investigator
National University Health System (NUHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by National University Hospital, Singapore at 1 site in Singapore.
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 3 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 27 Aug 2018. 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 Singapore. 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?
Number of patients with Post operative residual paralysis as measured by Train of Four (TOF) Ratio of < 0.9 (time frame: Through study completion, up to 4 months). 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 NCT02673853, which also lists 3 linked publications.
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 27 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.