Reversal of Neuromuscular Blockade in Diabetic Patients

Completed

• Conditions: Observation of Neuromuscular Block

• Registration Number: NCT02057861
• Lead Sponsor: Duzce University

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Study First Posted: 2014-02-07
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reversal of diabetic patients	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
hemodynamic changes	24 hours	Systolic, diastolic blood pressure and heart rate were recorded in the peroperative period

Trial Locations

Locations (1)

Duzce University; 🇹🇷 Duzce, Turkey