Neuromuscular BlockadeNCT02930629
Residual Block in Postoperative Anaesthetic Care Unit
An observational study of Neuromuscular Blockade, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The purpose of this study is to assess the incidence of residual block in patients arriving in the Post Anaesthetic Care Unit (PACU) following surgery, and in those who have received neuromuscular blocking drugs (muscle relaxants). Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Train-of-Four (TOF) Watch
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2016to 18 Aug 2017
- 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: All patients 21 years old or older, who receive neuromuscular blocking drugs (muscle relaxants) as part of their anaesthesia for surgery, and who arrive in the postoperative anaesthesia care unit.
Who may be able to join
- All patients 21 years old or older, who receive neuromuscular blocking drugs (muscle relaxants) as part of their anaesthesia for surgery.
Who cannot join
- Patients who have neuromuscular disease
- Patients for whom applying train-of-four (to detect residual block) monitoring on their ulnar nerves is not possible
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Patrick Wong, MBBS FRCA, +6563214220, patrick.wong@singhealth.com.sg
Ruban Poopalalingam, MBBS MMED, +6563214220, ruban.poopalalingam@singhealth.com.sg
About this study
Official title: Assessment of Residual Paralysis in Patients in the Postoperative Anaesthetic Care Unit (PACU)
The purpose of this study is to assess the incidence of residual block in patients arriving in the Post Anaesthetic Care Unit (PACU) following surgery, and in those who have received neuromuscular blocking drugs (muscle relaxants). Residual block (decreased motor function) due to residual levels of muscle relaxants is associated with increased morbidity.
Read the detailed description
This is a prospective, cross sectional study. Adult patients undergoing surgery in the main operating theatres of Singapore General Hospital and requiring general anaesthesia and muscle relaxants will be enrolled and assessed over a 4 month period.
Explanation, handing over of the Participation Information Sheet, and consent taking for the research will be taken either: In the anaesthetic Pre-operative Evaluation Clinic (PEC) which takes place on average 1-2 weeks prior to surgery itself; or On the ward, as a portion of patients are admitted as an inpatient the day before surgery. This allows patients time to consider participation into the study.
The conduct of anaesthesia before arrival in PACU is left to the discretion of the attending anaesthetist. After arrival in PACU, patients are cared for by the PACU nurse and attending anaesthetist. The PI or co-investigators of the participants will follow up patients arriving in PACU if they fit the inclusion criteria i.e. who have received muscle relaxants during their anaesthetic.
Participants will have their neuromuscular function monitored using a TOF Watch. This is a neuromuscular monitor used to assess the twitch height of muscles when stimulated by small electrical currents. Assessing neuromuscular function at all stages of anaesthesia (during anaesthesia and during recovery from anaesthesia) is the standard of care and is considered "essential" as per guidelines from the Association of Anaesthetists of Great Britain and Ireland (2015).
The following are standards of care in PACU if patients are suspected of having residual block:
- Neuromuscular function will be assessed using clinical means (head lift and hand grip) but these are unreliable (false positives due to effects of anaesthetic agents and opioids rather than muscle relaxants)
- Neuromuscular function assessed by either TOF count (number of twitches) or TOF ratio (any fade in height of the four twitches) as per manufacturer's guidelines. Two ECG electrodes will be placed 4 cm apart over the path of the ulnar nerve of the wrist after cleaning the skin with alcohol swabs. The TOF force transducer will be placed on the volar aspect of the thumb. The TOF Watch leads will be attached to the electrodes and a TOF stimulus will be applied: four twitches at 2Hz (every 0.5 seconds), each twitch lasting 0.2ms, and at a current of 50 milliamperes (mA).
- Patients who have residual block will be closely monitored as per standard care in PACU, which include oxygen therapy, and monitoring (continuous ECG, respiratory rate, pulse oximetry, and 15 minutely non invasive blood pressure measurements). Those patients who have clinical signs and symptoms of residual block will be treated at the discretion of the PACU nurse and attending anaesthetic medical officer stationed in PACU
For the research study in PACU, patients will have the above (steps 1 to 3) irrespective of whether residual block is suspected.
In addition:
The TOF ratio will be measured as two sets of TOF ratio with an average of the two taken. As far as possible, the TOF will be done when patients are still slightly drowsy from the effects of anaesthesia in order to minimize any patient TOF discomfort. If there is >10% discrepancy between these two readings then two more TOF will be applied, and an average of the two closest measurement averaged. This will determine if the participant has residual block (defined at TOF<0.9).
Medical record review of data will be that from intraoperative period and PACU stay (usually one hour) and includes data already inputted into the anaesthetic charts:
- Patient data: age, weight, BMI, American Society of Anaesthesiologists (ASA) status, list of co-morbidities
- Surgical data: type of operation and duration
- Anaesthetic data: type, dose and timing of muscle relaxants and reversal used; type and method of neuromuscular monitoring used
- PACU data: time of arrival; heart rate, blood pressure, pulse oximetry and respiratory rate on admission; any adverse incidents (airway obstruction, desaturation (SpO2<95%), complaints of muscle weakness or blurred/double vision).
- Conditions
- Neuromuscular Blockade
- Being tested
- Train-of-Four (TOF) Watch
- Keywords
- Recovery Period, Anesthesia, Neuromuscular Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Train-of-Four (TOF) WatchDevice
For patients, on arriving in PACU after having had muscle relaxants during general anaesthesia
- Two ECG electrodes will be placed 4 cm apart over the path of the ulnar nerve of the wrist after cleaning the skin with alcohol swabs.
- The TOF force transducer will be placed on the volar aspect of the thumb.
- The TOF Watch leads will be attached to the ECG electrodes.
- A TOF stimulus will be applied: four twitches at 2Hz (every 0.5 seconds), each twitch lasting 0.2ms, and at a current of 50 mA. As far as possible, this will be done when patients are still slightly drowsy from the effects of anaesthesia.
- Two TOF ratio will be elicited (two sets of four twitches 15 seconds apart), and an average of the two taken
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of residual block (train of four <0.9) after receiving neuromuscular block for anaesthesia for surgery
Train of four is measured at the adductor pollicis using TOF Watch acceleromyography
Measured: Within one hour of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion18 Aug 2017 (estimated)
- Study completion18 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wong, MBBS FRCA, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930629
- Sponsor's protocol ID
- 1607 PACU residual block
- Other IDs
- 2016/2478
- Status last verified
- Apr 2017
- First submitted
- 10 Oct 2016
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Plaud B, Debaene B, Donati F, Marty J. Residual paralysis after emergence from anesthesia. Anesthesiology. 2010 Apr;112(4):1013-22. doi: 10.1097/ALN.0b013e3181cded07. No abstract available.
PubMed 20234315Brull SJ, Prielipp RC. Reversal of neuromuscular blockade: "identification friend or foe". Anesthesiology. 2015 Jun;122(6):1183-5. doi: 10.1097/ALN.0000000000000675. No abstract available.
PubMed 25856292
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Residual Paralysis in Patients in the Postoperative Anaesthetic Care Unit (PACU)
- ClinicalTrials.gov ID
- NCT02930629
- Acronym / sponsor ID
- 1607 PACU residual block
- Conditions
- Neuromuscular Blockade
- Keywords
- Recovery Period, Anesthesia, Neuromuscular Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 18 Aug 2017 (estimated)
- Study completion
- 18 Aug 2017 (estimated)
- First posted
- 12 Oct 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.
The purpose of this study is to assess the incidence of residual block in patients arriving in the Post Anaesthetic Care Unit (PACU) following surgery, and in those who have received neuromuscular blocking drugs (muscle relaxants). Residual block (decreased motor function) due to residual levels of muscle relaxants is associated with increased morbidity.
Detailed description
This is a prospective, cross sectional study. Adult patients undergoing surgery in the main operating theatres of Singapore General Hospital and requiring general anaesthesia and muscle relaxants will be enrolled and assessed over a 4 month period.
Explanation, handing over of the Participation Information Sheet, and consent taking for the research will be taken either: In the anaesthetic Pre-operative Evaluation Clinic (PEC) which takes place on average 1-2 weeks prior to surgery itself; or On the ward, as a portion of patients are admitted as an inpatient the day before surgery. This allows patients time to consider participation into the study.
The conduct of anaesthesia before arrival in PACU is left to the discretion of the attending anaesthetist. After arrival in PACU, patients are cared for by the PACU nurse and attending anaesthetist. The PI or co-investigators of the participants will follow up patients arriving in PACU if they fit the inclusion criteria i.e. who have received muscle relaxants during their anaesthetic.
Participants will have their neuromuscular function monitored using a TOF Watch. This is a neuromuscular monitor used to assess the twitch height of muscles when stimulated by small electrical currents. Assessing neuromuscular function at all stages of anaesthesia (during anaesthesia and during recovery from anaesthesia) is the standard of care and is considered "essential" as per guidelines from the Association of Anaesthetists of Great Britain and Ireland (2015).
The following are standards of care in PACU if patients are suspected of having residual block:
- Neuromuscular function will be assessed using clinical means (head lift and hand grip) but these are unreliable (false positives due to effects of anaesthetic agents and opioids rather than muscle relaxants)
- Neuromuscular function assessed by either TOF count (number of twitches) or TOF ratio (any fade in height of the four twitches) as per manufacturer's guidelines. Two ECG electrodes will be placed 4 cm apart over the path of the ulnar nerve of the wrist after cleaning the skin with alcohol swabs. The TOF force transducer will be placed on the volar aspect of the thumb. The TOF Watch leads will be attached to the electrodes and a TOF stimulus will be applied: four twitches at 2Hz (every 0.5 seconds), each twitch lasting 0.2ms, and at a current of 50 milliamperes (mA).
- Patients who have residual block will be closely monitored as per standard care in PACU, which include oxygen therapy, and monitoring (continuous ECG, respiratory rate, pulse oximetry, and 15 minutely non invasive blood pressure measurements). Those patients who have clinical signs and symptoms of residual block will be treated at the discretion of the PACU nurse and attending anaesthetic medical officer stationed in PACU
For the research study in PACU, patients will have the above (steps 1 to 3) irrespective of whether residual block is suspected.
In addition:
The TOF ratio will be measured as two sets of TOF ratio with an average of the two taken. As far as possible, the TOF will be done when patients are still slightly drowsy from the effects of anaesthesia in order to minimize any patient TOF discomfort. If there is >10% discrepancy between these two readings then two more TOF will be applied, and an average of the two closest measurement averaged. This will determine if the participant has residual block (defined at TOF<0.9).
Medical record review of data will be that from intraoperative period and PACU stay (usually one hour) and includes data already inputted into the anaesthetic charts:
- Patient data: age, weight, BMI, American Society of Anaesthesiologists (ASA) status, list of co-morbidities
- Surgical data: type of operation and duration
- Anaesthetic data: type, dose and timing of muscle relaxants and reversal used; type and method of neuromuscular monitoring used
- PACU data: time of arrival; heart rate, blood pressure, pulse oximetry and respiratory rate on admission; any adverse incidents (airway obstruction, desaturation (SpO2<95%), complaints of muscle weakness or blurred/double vision).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients 21 years old or older, who receive neuromuscular blocking drugs (muscle relaxants) as part of their anaesthesia for surgery, and who arrive in the postoperative anaesthesia care unit.
Key inclusion criteria (1 listed)
- All patients 21 years old or older, who receive neuromuscular blocking drugs (muscle relaxants) as part of their anaesthesia for surgery.
Key exclusion criteria (2 listed)
- Patients who have neuromuscular disease
- Patients for whom applying train-of-four (to detect residual block) monitoring on their ulnar nerves is not possible
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 |
|---|---|---|
| Train-of-Four (TOF) WatchFor patients, on arriving in PACU after having had muscle relaxants during general anaesthesia * Two ECG electrodes will be placed 4 cm apart over the path of the ulnar nerve of the wrist after cleaning the skin with alcohol swabs. * The TOF force transducer will be placed on the volar aspect of the thumb. * The TOF Watch leads will be attached to the ECG electrodes. * A TOF stimulus will be applied: four twitches at 2Hz (every 0.5 seconds), each twitch lasting 0.2ms, and at a current of 50 mA. As far as possible, this will be done when patients are still slightly drowsy from the effects of anaesthesia. * Two TOF ratio will be elicited (two sets of four twitches 15 seconds apart), and an average of the two taken | Device | – |
Primary outcome
Evidence of residual block (train of four <0.9) after receiving neuromuscular block for anaesthesia for surgery
Time frame: Within one hour of surgery
Train of four is measured at the adductor pollicis using TOF Watch acceleromyography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Results publication: PubMed 20234315Plaud B, Debaene B, Donati F, Marty J. Residual paralysis after emergence from anesthesia. Anesthesiology. 2010 Apr;112(4):1013-22. doi: 10.1097/ALN.0b013e3181cded07. No abstract available.
- Results publication: PubMed 25856292Brull SJ, Prielipp RC. Reversal of neuromuscular blockade: "identification friend or foe". Anesthesiology. 2015 Jun;122(6):1183-5. doi: 10.1097/ALN.0000000000000675. No abstract available.
- Individual participant dataSharing planned: No
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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.
Patrick Wong, MBBS FRCA principal investigator
Singapore General Hospital
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 Neuromuscular Blockade, run by Singapore General Hospital 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Wong, MBBS FRCA (+6563214220, patrick.wong@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of residual block (train of four <0.9) after receiving neuromuscular block for anaesthesia for surgery (time frame: Within one hour of surgery). 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 NCT02930629, which also lists 2 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 1 May 2017.