Reversal of Neuromuscular Blockade in Diabetic Patients | NCT02057861

Studies
Reversal of Neuromuscular Blockade in Diabetic Patients

NCT02057861

Sponsor

Duzce University

Status

Completed

Last Update Posted

Feb 7, 2014Estimated

Enrollment

45Actual

Phase

Not provided

Conditions

Observation of Neuromuscular Block

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Feb 5, 2014

First Submission Date that Met QC Criteria

Feb 6, 2014

First Posted Date

Feb 7, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2014

Last Update Posted Date

Feb 7, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
hemodynamic changes	Systolic, diastolic blood pressure and heart rate were recorded in the peroperative period	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

The patients (diabetic and non-diabetic) between 18-65 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
yavuz demiraran, professor	Duzce University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duzce University		Düzce		81620	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

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Browse Branches

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