Reversal of Neuromuscular Blockade in Diabetic Patients
|ClinicalTrials.gov Identifier: NCT02057861|
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
|Condition or disease|
|Observation of Neuromuscular Block|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||45 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||9 Months|
|Official Title:||The Comparison of Reversal of Neuromuscular Blockade in Diabetic and Non-Diabetic Patients|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||December 2013|
non-diabetic group; 2 mg/kg sugammadex iv, postoperatively Extubation times were recorded.
Diabetic group; 2 mg/kg sugammadex iv, postoperatively Extubation times were recorded
- reversal of diabetic patients [ Time Frame: 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.
- hemodynamic changes [ Time Frame: 24 hours ]Systolic, diastolic blood pressure and heart rate were recorded in the peroperative period
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057861
|Duzce, Turkey, 81620|
|Principal Investigator:||yavuz demiraran, professor||Duzce University|