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Completed

NCT Number: NCT02057861

Reversal of Neuromuscular Blockade in Diabetic Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duzce University

Düzce, 81620, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. hemodynamic changes

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study title

The Comparison of Reversal of Neuromuscular Blockade in Diabetic and Non-Diabetic Patients

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 7, 2014
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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