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

• Conditions: Neuromuscular Transmission Disorder; Diabetes Mellitus, Type 2
• Interventions: Device: monitoring of neuromuscular function

• Registration Number: NCT03737942
• Lead Sponsor: Assiut University

Brief 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 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 Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-04
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-13
• Study Start: 2018-11-15
• Last Update Submitted: 2018-11-18
• Last Update Posted: 2018-11-20
• Primary Completion: 2019-01-15
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	monitoring of neuromuscular function	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
T2DM without neuropathy	monitoring of neuromuscular function	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
T2DM with neuropathy	monitoring of neuromuscular function	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

Primary Outcome Measures

Name	Time	Method
neuromuscular monitoring	before operation,till one hour	Tetanic stimulus , 50 Hz during 5 seconds (tetanic preconditioning).

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt