Reversal of Neuromuscular Blockade in Diabetic Patients

NCT ID: NCT02057861

Last Updated: 2014-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Observation of Neuromuscular Block

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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non-diabetic

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

No interventions assigned to this group

diabetic

Diabetic group; 2 mg/kg sugammadex iv, postoperatively Extubation times were recorded

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duzce University

OTHER

Sponsor Role lead

Responsible Party

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yavuz demiraran

Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yavuz demiraran, professor

Role: PRINCIPAL_INVESTIGATOR

Duzce University

Locations

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Duzce University

Düzce, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ozlemersoy

Identifier Type: -

Identifier Source: org_study_id

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