Clinical trial NCT02057861: Reversal of Neuromuscular Blockade in Diabetic Patients
Official title: The Comparison of Reversal of Neuromuscular Blockade in Diabetic and Non-Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Observation of Neuromuscular Block
Keywords: diabetes mellitus
neuromuscular blockade
sugammadex
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients (diabetic and non-diabetic) between 18-65 years

Brief summary: In this study the investigators aimed to compare the time of antagonism and intensity of effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic patients.

Detailed description: Aim: In this study the investigators aimed to compare the time of antagonism and intensity of effect of sugammadex which is used for antagonism of rocuronium on diabetic and non-diabetic patients.

Methods: Included patients were divided into 2 groups: diabetic (n=21) and non-diabetic (n=20). All patients were premedicated. After arrival in the operating room, all patients were monitorised with Datex Ohmeda S/5 Anesthesia Machine and electrocardiography (DII derivation), hemodynamic variables, respiratory rate, and inspiratory sevoflurane concentrations were recorded. Neuromuscular monitoring system was used. Anesthesia was induced with propofol 2 mg/kg and fentanyl 1 mcg/kg. After the loss of eyelid reflex the neuromuscular monitoring system automatically identified supramaximal stimulating currents and after that rocuronium 0,6 mg/kg was given. Train of four (TOF) stimulation with the supramaximal current were applied and by recording of second TOF value (TOF2) the patient was intubated. Anesthesia was maintained with 50% O2 + 50% air and sevoflurane of 1-2 % concentration. TOF stimulation was applied and recorded every 20 seconds. Intraoperatively by return T2 rocuronium 0,15 mg/kg was given. T2i time was recorded as intubation time and T2d time was recorded as clinical effect time. At the end of the operation sugammadex 2 mg/kg was given. When TOF rate reached 0,9 patients were extubated and the time was recorded.

Eligibility criteria: Inclusion Criteria:

* The patients (diabetic and non-diabetic) between 18-65 years with risk of anesthesia I-II,
* For diabetic group patients with Diabetes mellitus Type 2 over 10 years.
* For non-diabetic group patients without any glucose metabolism disease

Exclusion Criteria:

* myasthenia gravis, myotonic dystrophia, motor neuron diseases
* diabetic neuropathy and nephropathy
* hepatic, renal and cardiac diseases

Primary outcomes:
measure: reversal of diabetic patients
timeFrame: 24 hours
Secondary outcomes:
measure: hemodynamic changes
timeFrame: 24 hours
Other outcomes:
Locations:
city: Duzce
country: Turkey
facility: Duzce University
Study officials:
affiliation: Duzce University
name: yavuz demiraran, professor
role: PRINCIPAL_INVESTIGATOR
References: