Muscle RelaxantsPhase 4NCT02425449
Fade Upon TOF Stimulation Induced by Succinylcholine
A Phase 4 study testing Succinylcholine in people with Muscle Relaxants, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
Muscle relaxants are medications used during surgery to facilitate surgical access. The effect of the muscle relaxant medications is measured by stimulation a motor nerve and measuring the force of the resultant muscle contraction. Based on the mechanism of action, two kinds of muscle relaxants are described. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Relaxants
- What is being tested?
- Succinylcholine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 4 Jan 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA PS I or II,
- 18-60 years of age of either sex,
- with a BMI<25Kg/m2
Who cannot join
- presence of any disease involving the neuromuscular system.
- Presence of any neurologic illness eg . Paraplegia or hemiplegia, spinal cord injuries, stroke, multiple sclerosis.
- No liver or kidney disease.
- Known allergy to succinylcholine.
- Family history of malignant hyperthermia.
- Known pseudocholinesterase deficiency.
Show all 22Show fewer
- Any skin burns within the last 1 year.
- We would also exclude subjects with;
- Central core disease,
- duchenne or Becker muscular dystrophy,
- osteogenesis imperfecta,
- Noonan syndrome,
- arthrogryposis multiplex,
- congenital,
- myotonia,
- neuroleptic malignant syndrome,
- multiminicore disease,
- King Denborough syndrome,
- Native American myopathy,
- hypokalemic periodic paralysis or
- a history of rhabdomyolysis.
- We would also exclude any subject with a history of cardiac arrhythmias.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo, Health Science Campus
Toledo, Ohio, 43614
About this study
Official title: Characterizing Fade Upon Train-of Four Stimulation During Onset and Offset of Neuromuscular Block Produced by Succinlycholine
Muscle relaxants are medications used during surgery to facilitate surgical access. The effect of the muscle relaxant medications is measured by stimulation a motor nerve and measuring the force of the resultant muscle contraction. Based on the mechanism of action, two kinds of muscle relaxants are described. First a nondepolarizing muscle relaxant and the second kind is the depolarizing muscle relaxant. These two kinds of muscle relaxants can be distinguished by rapidly stimulating the nerve 4 times over 2 seconds (Train of four or TOF). The nondepolarizing muscle relaxants produce fade ie successive muscle contractions are less forceful than the preceding ones. Whereas the depolarizing muscle relaxants are generally believed to produce four contractions of equal strength. However, there is some indication that this may not be entirely correct. There is evidence that depolarizing muscle relaxants also may produce fade. The investigators are conducting the following study to determine if indeed depolarizing muscle relaxants produce fade. The investigators would also like to characterize the fade ie differences during onset and offset of the block and the effect of the dose on the degree on the fade.
Read the detailed description
Muscle relaxants are frequently employed during anesthesia. These medications may be employed to facilitate tracheal intubation, mechanical ventilation or to allow better surgical access. All muscle relaxants act at the neuromuscular junction. Based on the mechanism of action, two kinds of muscle relaxants have been defined1. Nondepolarizing muscle relaxants are competitive antagonists of the neurotransmitter acetylcholine (Ach) at the neuromuscular junction. The second kind of muscle relaxant is the depolarizing muscle relaxant and succinylcholine is the only muscle relaxant in this class that is clinically used. The mechanism of action of succinylcholine is less clear. Succinylcholine appears to mimic the actions of acetylcholine but results in a longer duration of depolarization of the post synaptic membrane1.
The degree of muscle relaxation produced by these muscle relaxants is measured by stimulating a motor nerve and measuring either the force of the muscle contraction produced or its compound muscle action potential (CMAP). As the muscle relaxation increases, the force of muscle contraction or the amplitude of the electromyogram (EMG) is correspondingly reduced.
On occasion, to measure the degree of muscle weakness or paralysis caused by a muscle relaxant, instead of a single stimulus, trains of stimuli are applied2. One method of repetitive stimulation is to apply four stimuli over a two second period. This method of nerve stimulation is called Train-of-Four (TOF). When this form nerve stimulation (TOF) is applied to patients who have been given nondepolarizing muscle relaxants -there is fade. Fade means that the force of successive muscle contractions is less than the preceding contraction3. The second contraction is less than the first, the third less than the second and so on. The degree of fade appears to have some reasonably well defined relationship to the degree of relaxation produced3.
The classic teaching in the anesthetic literature is that depolarizing muscle relaxants do not produce fade upon repetitive stimulation. It means that upon repetitive stimulation, the successive contractions are similar. This is one of the defining features of a depolarizing block and is called a Phase I block. The traditional teaching is that when a depolarizing muscle relaxant is administered in large or repetitive doses, a Phase II block develops. The phase II block has characteristics similar to those of a nondepolarizing muscle relaxant (ie fade on repetitive or TOF stimulation). De Jong and Freund first proposed that this differentiation between deplolarizing and nondepolarizing block based upon fade may not be as clear cut. These investigators demonstrated that succinylcholine caused fade upon repetitive stimulation right from the outset of the neuromuscular block. Other investigators have also demonstrated that succinylcholine causes fade from the initiation of the neuromuscular block. If it can be conclusively demonstrated that succinylcholine causes fade, then fade would be less useful in differentiating a depolarizing from a nondepolarizing block. We have previously investigated and defined the fade caused by nondepolarizing muscle relaxants. Using the experience we have gained in studying fade with nondepolarizing muscle relaxants, we would like to now define the characteristics of fade (if any) caused by succinylcholine.
Method: We intend to enroll fifty healthy adults, 18-60 years of age of either sex who are scheduled to undergo a surgical procedure under general anesthesia. Only subjects with a BMI <25 Kg/m2 will be enrolled. Only subjects free from any hepatic or renal disease will be included. We will exclude any subjects with known allergy to succinylcholine, family history of malignant hyperthermia or any history of skeletal myopathy. We will also exclude subjects that have recently sustained burns, or any illness resulting denervation injury (paraplegia or hemiplegia).
The subjects will give an informed consent prior to the participation in the study. All patients will receive 2 mg of midazolam for premedication. Anesthesia will be induced with the intravenous administration of fentanyl 5-6 µg/kg and propofol 2-3 mg/kg. Following tracheal intubation, anesthesia will be maintained with 70% nitrous oxide in oxygen supplemented with an infusion of propofol (120 -150 µg/kg/min). Ventilation will be controlled to maintain normocapnia (end-tidal carbon di oxide 35-40 mmHg).
After the commencement of the anesthesia monitoring of neuromuscular transmission will be commenced. Ulnar nerve at the wrist will be stimulated in a TOF sequence (2 Hz every 12 seconds). The resultant force of contraction of the adductor pollicis will be recorded using a mechanomyograph. After obtaining a stable muscle contraction, succinylcholine will be administered. The subjects will be randomly allocated to one of five groups. Group 1 will receive 0.1 mg/kg, group 2 -0.15 mg/kg, group 3 -0.2 mg/kg, group 4 -0.25 mg/kg, group 5 -0.3 mg/kg. Muscle contraction will be recorded until the force of muscle contraction returns to baseline (6-8 minutes). At this time the study will be concluded. Further conduct of the anesthetic will be at the discretion of the subject's primary anesthesiologist.
Data Analysis: We intend to plot the force of all four muscle contractions from immediately preceding the injection succinylcholine to complete recovery of the muscle contraction. We would then plot the force of the first twitch (T1) against the ratio of the fourth to the first twitch (T4/T1 ratio) for each individual subject. This plot will allow us to determine if there is any difference in fade characteristics between onset and offset of muscle relaxant effect.
- Conditions
- Muscle Relaxants
- Being tested
- Succinylcholine
- Keywords
- succinylcholine, depolarizing muscle relaxants, pharmacologic effects
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuccinylcholineDrug
will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
| Study group | Role | What they receive |
|---|---|---|
| 01 mg/kg | Experimental | Succinylcholine 0.1 mg/kg will be administered and TOF ratio measured before and after the administration until stable Receives: Drug: Succinylcholine |
| 0.15 mg/kg | Experimental | Succinylcholine 0.15 mg/kg will be administered and TOF ratio measured before and after the administration until stable Receives: Drug: Succinylcholine |
| 0.2 mg/kg | Experimental | Succinylcholine 0.2 mg/kg will be administered and TOF ratio measured before and after the administration until stable Receives: Drug: Succinylcholine |
| 0.25 mg/kg | Experimental | Succinylcholine 0.25 mg/kg will be administered and TOF ratio measured before and after the administration until stable Receives: Drug: Succinylcholine |
| 0.3 mg/kg | Experimental | Succinylcholine 0.3 mg/kg will be administered and TOF ratio measured before and after the administration until stable Receives: Drug: Succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fade on Train of Four Stimulation
We stimulated the ulnar nerve at the wrist four times (over 1.5 seconds) every 20 seconds. We measured the ratio of the fourth contraction to the first contraction before and after the administration of succinylcholine. Before administering succinylcholine the ratio is normally one. After the administration of succinylcholine the first contraction diminishes, but the fourth contraction diminishes even more. This results in a ratio of T4 to T1 being less than one. The lowest ratio recorded after the administration after the administration of succinylcholine is reported as our outcome measure.
Measured: for the duration of the effect of succinylcholine generally expected to be 6-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion4 Jan 2017
- Study completion4 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Muscle RelaxantsStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shashi Bhatt, MD, University of Toledo Health Science Campus
- Investigators
- Shashi Bhatt, MD, Principal investigator, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425449
- Sponsor's protocol ID
- UTIRB 200538
- Status last verified
- Dec 2017
- First submitted
- 14 Apr 2015
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Fade Upon Train-of Four Stimulation During Onset and Offset of Neuromuscular Block Produced by Succinlycholine
- ClinicalTrials.gov ID
- NCT02425449
- Acronym / sponsor ID
- UTIRB 200538
- Conditions
- Muscle Relaxants
- Keywords
- succinylcholine, depolarizing muscle relaxants, pharmacologic effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 24 Apr 2015 (estimated)
- Results
- Posted 2 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Muscle relaxants are medications used during surgery to facilitate surgical access. The effect of the muscle relaxant medications is measured by stimulation a motor nerve and measuring the force of the resultant muscle contraction. Based on the mechanism of action, two kinds of muscle relaxants are described. First a nondepolarizing muscle relaxant and the second kind is the depolarizing muscle relaxant. These two kinds of muscle relaxants can be distinguished by rapidly stimulating the nerve 4 times over 2 seconds (Train of four or TOF). The nondepolarizing muscle relaxants produce fade ie successive muscle contractions are less forceful than the preceding ones. Whereas the depolarizing muscle relaxants are generally believed to produce four contractions of equal strength. However, there is some indication that this may not be entirely correct. There is evidence that depolarizing muscle relaxants also may produce fade. The investigators are conducting the following study to determine if indeed depolarizing muscle relaxants produce fade. The investigators would also like to characterize the fade ie differences during onset and offset of the block and the effect of the dose on the degree on the fade.
Detailed description
Muscle relaxants are frequently employed during anesthesia. These medications may be employed to facilitate tracheal intubation, mechanical ventilation or to allow better surgical access. All muscle relaxants act at the neuromuscular junction. Based on the mechanism of action, two kinds of muscle relaxants have been defined1. Nondepolarizing muscle relaxants are competitive antagonists of the neurotransmitter acetylcholine (Ach) at the neuromuscular junction. The second kind of muscle relaxant is the depolarizing muscle relaxant and succinylcholine is the only muscle relaxant in this class that is clinically used. The mechanism of action of succinylcholine is less clear. Succinylcholine appears to mimic the actions of acetylcholine but results in a longer duration of depolarization of the post synaptic membrane1.
The degree of muscle relaxation produced by these muscle relaxants is measured by stimulating a motor nerve and measuring either the force of the muscle contraction produced or its compound muscle action potential (CMAP). As the muscle relaxation increases, the force of muscle contraction or the amplitude of the electromyogram (EMG) is correspondingly reduced.
On occasion, to measure the degree of muscle weakness or paralysis caused by a muscle relaxant, instead of a single stimulus, trains of stimuli are applied2. One method of repetitive stimulation is to apply four stimuli over a two second period. This method of nerve stimulation is called Train-of-Four (TOF). When this form nerve stimulation (TOF) is applied to patients who have been given nondepolarizing muscle relaxants -there is fade. Fade means that the force of successive muscle contractions is less than the preceding contraction3. The second contraction is less than the first, the third less than the second and so on. The degree of fade appears to have some reasonably well defined relationship to the degree of relaxation produced3.
The classic teaching in the anesthetic literature is that depolarizing muscle relaxants do not produce fade upon repetitive stimulation. It means that upon repetitive stimulation, the successive contractions are similar. This is one of the defining features of a depolarizing block and is called a Phase I block. The traditional teaching is that when a depolarizing muscle relaxant is administered in large or repetitive doses, a Phase II block develops. The phase II block has characteristics similar to those of a nondepolarizing muscle relaxant (ie fade on repetitive or TOF stimulation). De Jong and Freund first proposed that this differentiation between deplolarizing and nondepolarizing block based upon fade may not be as clear cut. These investigators demonstrated that succinylcholine caused fade upon repetitive stimulation right from the outset of the neuromuscular block. Other investigators have also demonstrated that succinylcholine causes fade from the initiation of the neuromuscular block. If it can be conclusively demonstrated that succinylcholine causes fade, then fade would be less useful in differentiating a depolarizing from a nondepolarizing block. We have previously investigated and defined the fade caused by nondepolarizing muscle relaxants. Using the experience we have gained in studying fade with nondepolarizing muscle relaxants, we would like to now define the characteristics of fade (if any) caused by succinylcholine.
Method: We intend to enroll fifty healthy adults, 18-60 years of age of either sex who are scheduled to undergo a surgical procedure under general anesthesia. Only subjects with a BMI <25 Kg/m2 will be enrolled. Only subjects free from any hepatic or renal disease will be included. We will exclude any subjects with known allergy to succinylcholine, family history of malignant hyperthermia or any history of skeletal myopathy. We will also exclude subjects that have recently sustained burns, or any illness resulting denervation injury (paraplegia or hemiplegia).
The subjects will give an informed consent prior to the participation in the study. All patients will receive 2 mg of midazolam for premedication. Anesthesia will be induced with the intravenous administration of fentanyl 5-6 µg/kg and propofol 2-3 mg/kg. Following tracheal intubation, anesthesia will be maintained with 70% nitrous oxide in oxygen supplemented with an infusion of propofol (120 -150 µg/kg/min). Ventilation will be controlled to maintain normocapnia (end-tidal carbon di oxide 35-40 mmHg).
After the commencement of the anesthesia monitoring of neuromuscular transmission will be commenced. Ulnar nerve at the wrist will be stimulated in a TOF sequence (2 Hz every 12 seconds). The resultant force of contraction of the adductor pollicis will be recorded using a mechanomyograph. After obtaining a stable muscle contraction, succinylcholine will be administered. The subjects will be randomly allocated to one of five groups. Group 1 will receive 0.1 mg/kg, group 2 -0.15 mg/kg, group 3 -0.2 mg/kg, group 4 -0.25 mg/kg, group 5 -0.3 mg/kg. Muscle contraction will be recorded until the force of muscle contraction returns to baseline (6-8 minutes). At this time the study will be concluded. Further conduct of the anesthetic will be at the discretion of the subject's primary anesthesiologist.
Data Analysis: We intend to plot the force of all four muscle contractions from immediately preceding the injection succinylcholine to complete recovery of the muscle contraction. We would then plot the force of the first twitch (T1) against the ratio of the fourth to the first twitch (T4/T1 ratio) for each individual subject. This plot will allow us to determine if there is any difference in fade characteristics between onset and offset of muscle relaxant effect.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 01 mg/kg | Experimental | Drug: SuccinylcholineSuccinylcholine 0.1 mg/kg will be administered and TOF ratio measured before and after the administration until stable |
| 0.15 mg/kg | Experimental | Drug: SuccinylcholineSuccinylcholine 0.15 mg/kg will be administered and TOF ratio measured before and after the administration until stable |
| 0.2 mg/kg | Experimental | Drug: SuccinylcholineSuccinylcholine 0.2 mg/kg will be administered and TOF ratio measured before and after the administration until stable |
| 0.25 mg/kg | Experimental | Drug: SuccinylcholineSuccinylcholine 0.25 mg/kg will be administered and TOF ratio measured before and after the administration until stable |
| 0.3 mg/kg | Experimental | Drug: SuccinylcholineSuccinylcholine 0.3 mg/kg will be administered and TOF ratio measured before and after the administration until stable |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA PS I or II,
- 18-60 years of age of either sex,
- with a BMI<25Kg/m2
Key exclusion criteria (22 listed)
- presence of any disease involving the neuromuscular system.
- Presence of any neurologic illness eg . Paraplegia or hemiplegia, spinal cord injuries, stroke, multiple sclerosis.
- No liver or kidney disease.
- Known allergy to succinylcholine.
- Family history of malignant hyperthermia.
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 |
|---|---|---|
| Succinylcholinewill be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5. | Drug | 0.15 mg/kg, 0.2 mg/kg, 0.25 mg/kg, 0.3 mg/kg, 01 mg/kg |
Primary outcome
Fade on Train of Four Stimulation
Time frame: for the duration of the effect of succinylcholine generally expected to be 6-10 minutes
We stimulated the ulnar nerve at the wrist four times (over 1.5 seconds) every 20 seconds. We measured the ratio of the fourth contraction to the first contraction before and after the administration of succinylcholine. Before administering succinylcholine the ratio is normally one. After the administration of succinylcholine the first contraction diminishes, but the fourth contraction diminishes even more. This results in a ratio of T4 to T1 being less than one. The lowest ratio recorded after the administration after the administration of succinylcholine is reported as our outcome measure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Shashi Bhatt, MD principal investigator
University of Toledo
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 Succinylcholine in people with Muscle Relaxants, run by University of Toledo Health Science Campus 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 3 inclusion and 22 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 2 Jan 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 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?
Yes. Results are posted in the registry (first posted 2 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fade on Train of Four Stimulation (time frame: for the duration of the effect of succinylcholine generally expected to be 6-10 minutes). 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 2 Jan 2018.