NCT02057861

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2014

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

7 months

First QC Date

February 5, 2014

Last Update Submit

February 6, 2014

Conditions

Observation of Neuromuscular Block

Keywords

diabetes mellitusneuromuscular blockadesugammadex

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • hemodynamic changes

    24 hours

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • myasthenia gravis, myotonic dystrophia, motor neuron diseases
  • diabetic neuropathy and nephropathy
  • hepatic, renal and cardiac diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duzce University

Düzce, 81620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • yavuz demiraran, professor

    Duzce University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 7, 2014

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

TU(1)