Neuromuscular Transmission DisorderNCT03737942
Effect of Type II Diabetes Mellitus With Neuropathy on the Clinical Use of Rocuronium
An observational study of Neuromuscular Transmission Disorder and Diabetes Mellitus, Type 2, run by Assiut University at 1 site in Egypt.
Trial summary
International Diabetes Federation estimates that there are now 415 million adults aged 20-79 with diabetes mellitus worldwide. By 2040 this will rise to 640 million. Although diabetes mellitus is highly prevalent in our environment and one of the most important challenges of modern medicine, only a handful of studies… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Transmission Disorder, Diabetes Mellitus, Type 2
- What is being tested?
- monitoring of neuromuscular function
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2018to Mar 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * patients with diabetes Mellitus type 2. * Patients with suspected difficult airway (Mallampati class III and IV, thyromental distance <6.5 cm, oral aperture <3.5 cm) were also excluded. * In relation to kidney function, patients with serum creatinine ≥1.5 mg/dl or more were excluded. * we excluded individuals with GPT or GOT enzyme values ≥42 IU/l or a body mass index (BMI) of <18.5 kg/m2 or > 30 kg/m2.
Who may be able to join
- adult patients aged from 18 years to 65 years.
- scheduled for abdominal surgery under general anesthesia
Who cannot join
- Patients with allergy to rocuronium
- those diagnosed with diseases that alter neuromuscular blocker response (e.g., Guillain-Barré syndrome, Duchenne type muscle dystrophies, etc.),
- patients receiving treatment with drugs capable of altering neuromuscular transmission or neuromuscular blocker response (e.g., antiseizure drugs, certain antibiotics, etc.).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut governorate
Asyut
Ghada M Aboelfadl, MD, 01005802086, ghadafadl77@gmail.com
About this study
Official title: Effect of Type II Diabetes Mellitus With Neuropathy on the Clinical Use of Rocuronium: A Pharmacodynamic Modelling Study
International Diabetes Federation estimates that there are now 415 million adults aged 20-79 with diabetes mellitus worldwide. By 2040 this will rise to 640 million. Although diabetes mellitus is highly prevalent in our environment and one of the most important challenges of modern medicine, only a handful of studies have examined the neuromuscular function in diabetic patients. The shortage of publications in this area is still more surprising if we consider that the neuromuscular blockers are one of the pillars in the administration of general anesthesia. Neuromuscular blockers during surgery are used in tracheal intubation and to improve surgical conditions.
Read the detailed description
In diabetic patients, neuropathy, microvascular and macrovascular complications are known clinical findings which require attention during anesthesia. Partial degeneration or segmental demyelination of the nerve fibers and loss of motor units have been reported in patients with diabetes mellitus as well. Therefore, the effects of a neuromuscular blocking agent should be important because of potential complications from incomplete reversal or residual paralysis during anesthesia maintenance. In a series of studies, vecuronium has been the only agent investigated in patients with diabetes mellitus and other diseases characterized by neuromuscular dysfunction. Delayed recovery from the neuromuscular block after vecuronium administration was shown in patients with diabetes mellitus. Currently, rocuronium, with its rapid onset of action, rapid recovery profile and inactive metabolites, is generally known as a safe agent for anesthesia under normal conditions. It is known that the pharmacokinetic properties of rocuronium can be altered in some diseases, such as renal or hepatic failure. However, it has not been investigated whether the effect of rocuronium on neuromuscular function is changed in the presence of neuropathy in diabetes mellitus patients or not. The rationale of our study arises from the finding of many studies that show different changes in the neurophysiological parameters in diabetes mellitus. In diabetic nerve, the conduction velocity of the action potential is decreased, the amplitude of action potentials, both sensory and motor, is smaller, and the latency time is elongated.
- Being tested
- monitoring of neuromuscular function
- Keywords
- diabetes mellitus, Neuromuscular Transmission
- Medical subject headings
- Neuromuscular Junction Diseases, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoring of neuromuscular functionDevice
Also called acceleromyographic device
started by percutaneous stimulation of the cubital nerve at the wrist level
| Study group | Role | What they receive |
|---|---|---|
| control group | Motor nerve conduction studies:
Were done on right ulner, right median, right common peroneal, and right anterior tibial nerves F-wave (for Median, Ulnar and common peroneal nerves) H-reflex study Receives: Device: monitoring of neuromuscular function | |
| T2DM without neuropathy | Motor nerve conduction studies:
Were done on right ulner, right median, right common peroneal, and right anterior tibial nerves F-wave (for Median, Ulnar and common peroneal nerves) H-reflex study Receives: Device: monitoring of neuromuscular function | |
| T2DM with neuropathy | Motor nerve conduction studies:
Were done on right ulner, right median, right common peroneal, and right anterior tibial nerves F-wave (for Median, Ulnar and common peroneal nerves) H-reflex study Receives: Device: monitoring of neuromuscular function |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuromuscular monitoring
Tetanic stimulus , 50 Hz during 5 seconds (tetanic preconditioning).
Measured: before operation,till one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start15 Nov 2018
- Primary completion15 Jan 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Transmission DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
- Investigators
- Ghada Abo Elfadl, M.D, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737942
- Sponsor's protocol ID
- Type II DM with Neuropathy
- Status last verified
- Nov 2018
- First submitted
- 4 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hafeez KR, Tuteja A, Singh M, Wong DT, Nagappa M, Chung F, Wong J. Postoperative complications with neuromuscular blocking drugs and/or reversal agents in obstructive sleep apnea patients: a systematic review. BMC Anesthesiol. 2018 Jul 19;18(1):91. doi: 10.1186/s12871-018-0549-x.
PubMed 30025517Nandi R, Basu SR, Sarkar S, Garg R. A comparison of haemodynamic responses between clinical assessment-guided tracheal intubation and neuromuscular block monitoring-guided tracheal intubation: A prospective, randomised study. Indian J Anaesth. 2017 Nov;61(11):910-915. doi: 10.4103/ija.IJA_93_17.
PubMed 29217857Kashiwai A, Suzuki T, Ogawa S. Sensitivity to rocuronium-induced neuromuscular block and reversibility with sugammadex in a patient with myotonic dystrophy. Case Rep Anesthesiol. 2012;2012:107952. doi: 10.1155/2012/107952. Epub 2012 Apr 9.
PubMed 22606401Huang L, Chen D, Li S. Streptozotocin diabetes attenuates the effects of nondepolarizing neuromuscular relaxants on rat muscles. Korean J Physiol Pharmacol. 2014 Dec;18(6):461-7. doi: 10.4196/kjpp.2014.18.6.461. Epub 2014 Dec 30.
PubMed 25598659
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Type II Diabetes Mellitus With Neuropathy on the Clinical Use of Rocuronium: A Pharmacodynamic Modelling Study
- ClinicalTrials.gov ID
- NCT03737942
- Acronym / sponsor ID
- Type II DM with Neuropathy
- Keywords
- diabetes mellitus, Neuromuscular Transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 13 Nov 2018 (actual)
- 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.
International Diabetes Federation estimates that there are now 415 million adults aged 20-79 with diabetes mellitus worldwide. By 2040 this will rise to 640 million. Although diabetes mellitus is highly prevalent in our environment and one of the most important challenges of modern medicine, only a handful of studies have examined the neuromuscular function in diabetic patients. The shortage of publications in this area is still more surprising if we consider that the neuromuscular blockers are one of the pillars in the administration of general anesthesia. Neuromuscular blockers during surgery are used in tracheal intubation and to improve surgical conditions.
Detailed description
In diabetic patients, neuropathy, microvascular and macrovascular complications are known clinical findings which require attention during anesthesia. Partial degeneration or segmental demyelination of the nerve fibers and loss of motor units have been reported in patients with diabetes mellitus as well. Therefore, the effects of a neuromuscular blocking agent should be important because of potential complications from incomplete reversal or residual paralysis during anesthesia maintenance. In a series of studies, vecuronium has been the only agent investigated in patients with diabetes mellitus and other diseases characterized by neuromuscular dysfunction. Delayed recovery from the neuromuscular block after vecuronium administration was shown in patients with diabetes mellitus. Currently, rocuronium, with its rapid onset of action, rapid recovery profile and inactive metabolites, is generally known as a safe agent for anesthesia under normal conditions. It is known that the pharmacokinetic properties of rocuronium can be altered in some diseases, such as renal or hepatic failure. However, it has not been investigated whether the effect of rocuronium on neuromuscular function is changed in the presence of neuropathy in diabetes mellitus patients or not. The rationale of our study arises from the finding of many studies that show different changes in the neurophysiological parameters in diabetes mellitus. In diabetic nerve, the conduction velocity of the action potential is decreased, the amplitude of action potentials, both sensory and motor, is smaller, and the latency time is elongated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Device: monitoring of neuromuscular functionMotor nerve conduction studies: Were done on right ulner, right median, right common peroneal, and right anterior tibial nerves F-wave (for Median, Ulnar and common peroneal nerves) H-reflex study |
| T2DM without neuropathy | – | Device: monitoring of neuromuscular functionMotor nerve conduction studies: Were done on right ulner, right median, right common peroneal, and right anterior tibial nerves F-wave (for Median, Ulnar and common peroneal nerves) H-reflex study |
| T2DM with neuropathy | – | Device: monitoring of neuromuscular functionMotor nerve conduction studies: Were done on right ulner, right median, right common peroneal, and right anterior tibial nerves F-wave (for Median, Ulnar and common peroneal nerves) H-reflex study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * patients with diabetes Mellitus type 2. * Patients with suspected difficult airway (Mallampati class III and IV, thyromental distance <6.5 cm, oral aperture <3.5 cm) were also excluded. * In relation to kidney function, patients with serum creatinine ≥1.5 mg/dl or more were excluded. * we excluded individuals with GPT or GOT enzyme values ≥42 IU/l or a body mass index (BMI) of <18.5 kg/m2 or > 30 kg/m2.
Key inclusion criteria (2 listed)
- adult patients aged from 18 years to 65 years.
- scheduled for abdominal surgery under general anesthesia
Key exclusion criteria (3 listed)
- Patients with allergy to rocuronium
- those diagnosed with diseases that alter neuromuscular blocker response (e.g., Guillain-Barré syndrome, Duchenne type muscle dystrophies, etc.),
- patients receiving treatment with drugs capable of altering neuromuscular transmission or neuromuscular blocker response (e.g., antiseizure drugs, certain antibiotics, etc.).
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 |
|---|---|---|
| monitoring of neuromuscular functionAlso: acceleromyographic devicestarted by percutaneous stimulation of the cubital nerve at the wrist level | Device | T2DM with neuropathy, T2DM without neuropathy, control group |
Primary outcome
neuromuscular monitoring
Time frame: before operation,till one hour
Tetanic stimulus , 50 Hz during 5 seconds (tetanic preconditioning).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Background: PubMed 30025517Hafeez KR, Tuteja A, Singh M, Wong DT, Nagappa M, Chung F, Wong J. Postoperative complications with neuromuscular blocking drugs and/or reversal agents in obstructive sleep apnea patients: a systematic review. BMC Anesthesiol. 2018 Jul 19;18(1):91. doi: 10.1186/s12871-018-0549-x.
- Background: PubMed 29217857Nandi R, Basu SR, Sarkar S, Garg R. A comparison of haemodynamic responses between clinical assessment-guided tracheal intubation and neuromuscular block monitoring-guided tracheal intubation: A prospective, randomised study. Indian J Anaesth. 2017 Nov;61(11):910-915. doi: 10.4103/ija.IJA_93_17.
- Background: PubMed 22606401Kashiwai A, Suzuki T, Ogawa S. Sensitivity to rocuronium-induced neuromuscular block and reversibility with sugammadex in a patient with myotonic dystrophy. Case Rep Anesthesiol. 2012;2012:107952. doi: 10.1155/2012/107952. Epub 2012 Apr 9.
- Background: PubMed 25598659Huang L, Chen D, Li S. Streptozotocin diabetes attenuates the effects of nondepolarizing neuromuscular relaxants on rat muscles. Korean J Physiol Pharmacol. 2014 Dec;18(6):461-7. doi: 10.4196/kjpp.2014.18.6.461. Epub 2014 Dec 30.
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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.
Ghada Abo Elfadl, M.D principal investigator
Assiut University
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 Transmission Disorder and Diabetes Mellitus, Type 2, run by Assiut University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Nov 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 Egypt. 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 ghada Abo Elfadl, M.D (01005802086, ghadafadl77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuromuscular monitoring (time frame: before operation,till one hour). 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 NCT03737942, which also lists 4 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 20 Nov 2018.