Reversal of Neuromuscular Blockade in Diabetic Patients

Sponsor
Duzce University (Other)
Overall Status
Completed
CT.gov ID
NCT02057861
Collaborator
(none)
45
1
11
4.1

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    45 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Comparison of Reversal of Neuromuscular Blockade in Diabetic and Non-Diabetic Patients
    Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Aug 1, 2013
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. hemodynamic changes [24 hours]

      Systolic, diastolic blood pressure and heart rate were recorded in the peroperative period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duzce University Duzce Turkey 81620

    Sponsors and Collaborators

    • Duzce University

    Investigators

    • Principal Investigator: yavuz demiraran, professor, Duzce University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    yavuz demiraran, Professor Doctor, Duzce University
    ClinicalTrials.gov Identifier:
    NCT02057861
    Other Study ID Numbers:
    • ozlemersoy
    First Posted:
    Feb 7, 2014
    Last Update Posted:
    Feb 7, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by yavuz demiraran, Professor Doctor, Duzce University

    Study Results

    No Results Posted as of Feb 7, 2014