Effect of Type II Diabetes Mellitus With Neuropathy on the Clinical Use of Rocuronium

November 18, 2018 updated by: Ghada Mohammed AboelFadl, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut governorate
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • adult patients aged from 18 years to 65 years.
  • scheduled for abdominal surgery under general anesthesia

Exclusion Criteria:

  • 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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: monitoring of neuromuscular function
started by percutaneous stimulation of the cubital nerve at the wrist level
Other Names:
  • acceleromyographic device
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
Device: monitoring of neuromuscular function
started by percutaneous stimulation of the cubital nerve at the wrist level
Other Names:
  • acceleromyographic device
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
Device: monitoring of neuromuscular function
started by percutaneous stimulation of the cubital nerve at the wrist level
Other Names:
  • acceleromyographic device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuromuscular monitoring
Time Frame: before operation,till one hour
Tetanic stimulus , 50 Hz during 5 seconds (tetanic preconditioning).
before operation,till one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ghada Abo Elfadl, M.D, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Anticipated)

January 15, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

November 4, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 18, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Type II DM with Neuropathy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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