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Reversal of Neuromuscular Blockade in Diabetic Patients

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ClinicalTrials.gov Identifier: NCT02057861
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
yavuz demiraran, 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.

Condition or disease
Observation of Neuromuscular Block

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 45 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Group/Cohort
non-diabetic
non-diabetic group; 2 mg/kg sugammadex iv, postoperatively Extubation times were recorded.
diabetic
Diabetic group; 2 mg/kg sugammadex iv, postoperatively Extubation times were recorded



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. hemodynamic changes [ Time Frame: 24 hours ]
    Systolic, diastolic blood pressure and heart rate were recorded in the peroperative period



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients (diabetic and non-diabetic) between 18-65 years
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057861


Locations
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Turkey
Duzce University
Duzce, Turkey, 81620
Sponsors and Collaborators
Duzce University
Investigators
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Principal Investigator: yavuz demiraran, professor Duzce University
Additional Information:

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Responsible Party: yavuz demiraran, Professor Doctor, Duzce University
ClinicalTrials.gov Identifier: NCT02057861    
Other Study ID Numbers: ozlemersoy
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014
Keywords provided by yavuz demiraran, Duzce University:
diabetes mellitus
neuromuscular blockade
sugammadex