Residual Neuromuscular BlockadePhase 4NCT02660398
Incidence and Severity of Residual Neuromuscular Blockade
A Phase 4 study testing Standardized NMBD Management in people with Residual Neuromuscular Blockade, run by University of Washington at 1 site in United States.
Trial summary
This prospective study will take place at Harborview Medical Center (HMC) and the University of Washington Medical Center (UWMC), and will enroll adult patients undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Neuromuscular Blockade
- What is being tested?
- Standardized NMBD Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 or older
- Will undergo open or laparoscopic abdominal surgery expected to last <6 hours at HMC or UWMC
- Have ASA physical status I-III
- Scheduled to have general anesthesia with at least 1 dose of nondepolarizing NMBD for endotracheal intubation or maintenance of neuromuscular block (NMB)
Who cannot join
- Allergy to NMBDs
- Patients with neuromuscular disease (myasthenia gravis or muscular dystrophy)
- Pregnant or lactating women
- Non-English speaking
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Incidence and Severity of Residual Neuromuscular Blockade With Application of a Protocol for Paralysis and Neostigmine Reversal of Rocuronium
This prospective study will take place at Harborview Medical Center (HMC) and the University of Washington Medical Center (UWMC), and will enroll adult patients undergoing abdominal surgery. The purpose of this study is to identify if the use of a specific plan to managing muscle relaxants will help decrease the risk of muscle weakness after general anesthesia with muscle relaxation in a population of patients undergoing abdominal surgery.
Read the detailed description
80 patients will be enrolled in this prospective study. The first 40 patients will serve as controls and will not have an intervention.
Patients who have surgery and receive general anesthesia often receive muscle relaxants called neuromuscular blocking drugs or NMBDs. NMBDs facilitate anesthesiologists' performance of tracheal intubation, provide muscle relaxation during surgery, and are sometimes administered to prevent movement. After surgery, an anesthesiologist monitors how the muscle relaxants wear off, and gives a drug to help reverse the effect of the NMBDs before the tracheal breathing tube is removed and a patient is awakened and taken to the postoperative care area (PACU).
A patient who receives NMBDs for their routine care can experience a leftover effect of the drug after their general anesthesia wears off. This condition is called Residual Neuromuscular Blockade. The management of NMBDs in patients for routine care vary by anesthesia provider. This study will explore if the use of a specific plan to managing muscle relaxants will help decrease the risk of muscle weakness after general anesthesia. Anesthesiologists routinely use peripheral nerve stimulators to assess the degree of muscle relaxation. Very commonly a series of 4 electrical stimulations are given over 2 seconds and each stimulation result in a twitch of the thumb when the ulnar nerve is stimulated at the wrist. This is called train-of-four (TOF) monitoring. When the patient is deeply relaxed, then all twitches are not present but as the drug effect diminishes over time, the twitches return. When 4 twitches are present, an exact measurement of the so-called TOF ratio can be calculated if an objective monitor is used. The ratio is the strength of the fourth twitch divided by the strength of the first twitch. The most commonly used reversal drug is neostigmine and it is known from previous research that it works more effectively if the muscle relaxation is not profound. In the intervention group, the investigators will confirm that the neuromuscular blockade has spontaneously recovered to a level where all 4 thumb twitches are present before neostigmine is administered.
All patients will have objective measurements obtained using the FDA approved monitor TOF-Watch SX. This monitor will be applied at the beginning of each case and will be calibrated immediately after induction of anesthesia. This is a simple automated process that takes less than 1 minute. The investigators will also obtain a TOF ratio measurement at the beginning of the case, before a muscle relaxant has been administered. This initial measurement allows for normalization of postoperative measurements. Measurement will be obtained again at the time of extubation, i.e. the removal of the breathing tube, which usually occurs in the operating room as the patient is awakened after surgery. Patients are routinely transferred to the post-anesthesia care unit (PACU) within minutes of being extubated and shortly after arrival to the PACU, the anesthesiologists transfers the care to PACU RNs. The investigators will obtain one more TOF-ratio measurement when the patient has just arrived to the post-anesthesia care unit (PACU).
- Conditions
- Residual Neuromuscular Blockade
- Being tested
- Standardized NMBD Management
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized NMBD ManagementProcedure or surgery
The intervention phase will introduce a standardized research protocol that spells out NMBD management, including how muscle relaxant should be administered and monitored, and how reversal with neostigmine should be done.
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | Our control group will consist of an observational cohort of 40 patients in whom we will make quantitative assessments of the Train-of-four ratio (TOF ratio). This is done using the TOF-Watch SX monitor. The monitor will be calibrated after induction of general anesthesia, measurement of the TOF ratio will be obtained at time of extubation and again at the time of arrival to the Post Anesthesia Care Unit (PACU). |
| Intervention | Other | The intervention consists of a protocol for intraoperative management of neuromuscular blockade with rocuronium and reversal with neostigmine. A train-of-four count of 4 at the thumb will be confirmed prior to administration of an adjusted dose of neostigmine. TOF ratio is measured in the same manner as for the Control group, it is done using the TOF-Watch SX monitor. The monitor will be calibrated after induction of general anesthesia, measurement of the TOF ratio will be obtained at time of extubation and again at the time of arrival to the Post Anesthesia Care Unit (PACU). Receives: Procedure: Standardized NMBD Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of residual paralysis
The incidence of residual paralysis defined as a TOF ratio <0.9 will be measured.
Measured: The outcome measure will be assessed at time of extubation
Secondary outcomes (1)
Incidence of severe residual paralysis
The incidence of severe residual paralysis defined as a TOF ratio <0.7 will be measured.
Measured: The outcome measure will be assessed at time of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionJan 2017
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 Residual Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Thilen, University of Washington
- Investigators
- Stephan Thilen, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660398
- Sponsor's protocol ID
- 50608
- Status last verified
- May 2019
- First submitted
- 15 Jan 2016
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thilen SR, Ng IC, Cain KC, Treggiari MM, Bhananker SM. Management of rocuronium neuromuscular block using a protocol for qualitative monitoring and reversal with neostigmine. Br J Anaesth. 2018 Aug;121(2):367-377. doi: 10.1016/j.bja.2018.03.029. Epub 2018 May 19.
PubMed 30032875
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
- Incidence and Severity of Residual Neuromuscular Blockade With Application of a Protocol for Paralysis and Neostigmine Reversal of Rocuronium
- ClinicalTrials.gov ID
- NCT02660398
- Acronym / sponsor ID
- 50608
- Conditions
- Residual Neuromuscular Blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Jan 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 prospective study will take place at Harborview Medical Center (HMC) and the University of Washington Medical Center (UWMC), and will enroll adult patients undergoing abdominal surgery. The purpose of this study is to identify if the use of a specific plan to managing muscle relaxants will help decrease the risk of muscle weakness after general anesthesia with muscle relaxation in a population of patients undergoing abdominal surgery.
Detailed description
80 patients will be enrolled in this prospective study. The first 40 patients will serve as controls and will not have an intervention.
Patients who have surgery and receive general anesthesia often receive muscle relaxants called neuromuscular blocking drugs or NMBDs. NMBDs facilitate anesthesiologists' performance of tracheal intubation, provide muscle relaxation during surgery, and are sometimes administered to prevent movement. After surgery, an anesthesiologist monitors how the muscle relaxants wear off, and gives a drug to help reverse the effect of the NMBDs before the tracheal breathing tube is removed and a patient is awakened and taken to the postoperative care area (PACU).
A patient who receives NMBDs for their routine care can experience a leftover effect of the drug after their general anesthesia wears off. This condition is called Residual Neuromuscular Blockade. The management of NMBDs in patients for routine care vary by anesthesia provider. This study will explore if the use of a specific plan to managing muscle relaxants will help decrease the risk of muscle weakness after general anesthesia. Anesthesiologists routinely use peripheral nerve stimulators to assess the degree of muscle relaxation. Very commonly a series of 4 electrical stimulations are given over 2 seconds and each stimulation result in a twitch of the thumb when the ulnar nerve is stimulated at the wrist. This is called train-of-four (TOF) monitoring. When the patient is deeply relaxed, then all twitches are not present but as the drug effect diminishes over time, the twitches return. When 4 twitches are present, an exact measurement of the so-called TOF ratio can be calculated if an objective monitor is used. The ratio is the strength of the fourth twitch divided by the strength of the first twitch. The most commonly used reversal drug is neostigmine and it is known from previous research that it works more effectively if the muscle relaxation is not profound. In the intervention group, the investigators will confirm that the neuromuscular blockade has spontaneously recovered to a level where all 4 thumb twitches are present before neostigmine is administered.
All patients will have objective measurements obtained using the FDA approved monitor TOF-Watch SX. This monitor will be applied at the beginning of each case and will be calibrated immediately after induction of anesthesia. This is a simple automated process that takes less than 1 minute. The investigators will also obtain a TOF ratio measurement at the beginning of the case, before a muscle relaxant has been administered. This initial measurement allows for normalization of postoperative measurements. Measurement will be obtained again at the time of extubation, i.e. the removal of the breathing tube, which usually occurs in the operating room as the patient is awakened after surgery. Patients are routinely transferred to the post-anesthesia care unit (PACU) within minutes of being extubated and shortly after arrival to the PACU, the anesthesiologists transfers the care to PACU RNs. The investigators will obtain one more TOF-ratio measurement when the patient has just arrived to the post-anesthesia care unit (PACU).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –Our control group will consist of an observational cohort of 40 patients in whom we will make quantitative assessments of the Train-of-four ratio (TOF ratio). This is done using the TOF-Watch SX monitor. The monitor will be calibrated after induction of general anesthesia, measurement of the TOF ratio will be obtained at time of extubation and again at the time of arrival to the Post Anesthesia Care Unit (PACU). |
| Intervention | Other | Procedure: Standardized NMBD ManagementThe intervention consists of a protocol for intraoperative management of neuromuscular blockade with rocuronium and reversal with neostigmine. A train-of-four count of 4 at the thumb will be confirmed prior to administration of an adjusted dose of neostigmine. TOF ratio is measured in the same manner as for the Control group, it is done using the TOF-Watch SX monitor. The monitor will be calibrated after induction of general anesthesia, measurement of the TOF ratio will be obtained at time of extubation and again at the time of arrival to the Post Anesthesia Care Unit (PACU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age 18 or older
- Will undergo open or laparoscopic abdominal surgery expected to last <6 hours at HMC or UWMC
- Have ASA physical status I-III
- Scheduled to have general anesthesia with at least 1 dose of nondepolarizing NMBD for endotracheal intubation or maintenance of neuromuscular block (NMB)
Key exclusion criteria (5 listed)
- Allergy to NMBDs
- Patients with neuromuscular disease (myasthenia gravis or muscular dystrophy)
- Pregnant or lactating women
- Non-English speaking
- Unable to provide informed consent
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 |
|---|---|---|
| Standardized NMBD ManagementThe intervention phase will introduce a standardized research protocol that spells out NMBD management, including how muscle relaxant should be administered and monitored, and how reversal with neostigmine should be done. | Procedure or surgery | Intervention |
Primary outcome
Incidence of residual paralysis
Time frame: The outcome measure will be assessed at time of extubation
The incidence of residual paralysis defined as a TOF ratio <0.9 will be measured.
1 secondary outcome
Incidence of severe residual paralysis
Time frame: The outcome measure will be assessed at time of extubation
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.
- Derived from this study: PubMed 30032875Thilen SR, Ng IC, Cain KC, Treggiari MM, Bhananker SM. Management of rocuronium neuromuscular block using a protocol for qualitative monitoring and reversal with neostigmine. Br J Anaesth. 2018 Aug;121(2):367-377. doi: 10.1016/j.bja.2018.03.029. Epub 2018 May 19.
- 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.
Stephan Thilen, MD principal investigator
University of Washington
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 Standardized NMBD Management in people with Residual Neuromuscular Blockade, run by University of Washington at 1 site in United States.
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 5 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 United States. 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 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?
Incidence of residual paralysis (time frame: The outcome measure will be assessed at time of extubation). 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 NCT02660398, 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 20 May 2019.