Reversal of Neuromuscular Blockade in Diabetic Patients

Observation of Neuromuscular Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057861
• Other study ID #: ozlemersoy
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: February 6, 2014
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Duzce University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Observation of Neuromuscular Block

Locations

Country	Name	City	State
Turkey	Duzce University	Duzce

Sponsors (1)

Lead Sponsor	Collaborator
Duzce University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reversal of diabetic patients	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.	24 hours	Yes
Secondary	hemodynamic changes	Systolic, diastolic blood pressure and heart rate were recorded in the peroperative period	24 hours	Yes