Effect of Diabetes Mellitus on Success of Spinal Anesthesia | NCT02294110

Studies
Effect of Diabetes Mellitus on Success of Spinal Anesthesia

NCT02294110

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Status

Completed

Last Update Posted

Aug 5, 2015Estimated

Enrollment

1,000Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

spinal anesthesia

Countries

Not provided

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

Aug 2015

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

Nov 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 12, 2014

First Submission Date that Met QC Criteria

Nov 18, 2014

First Posted Date

Nov 19, 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

Aug 4, 2015

Last Update Posted Date

Aug 5, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

İBRAHİM ÖZTÜRK, phase IV study of diabetes mellitus for spinal anesthesia failure, Diskapi Yildirim Beyazit Education and Research HospitalPrincipal Investigator

Lead Sponsor

Diskapi Yildirim Beyazit Education and Research HospitalOTHER_GOV

Collaborators

Not provided

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

Some of the authors says that diabetes mellitus is a risk factor for spinal anesthesia failure. However, that opinion was not determined in a trial. Thus the investigators aimed to investigate the effect of diabetes mellitus on spinal anesthesia.

Detailed Description

The investigators will include all of the patients who will undergo surgery with spinal anesthesia. The investigators will observe the patients with or without diabetes mellitus. And the investigators will examine the effect of diabetes mellitus on failure of spinal anesthesia.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
diabetes mellitus		spinal anesthesia	Other: spinal anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spinal anesthesia	Other	non diabetes mellitus	diabetes mellitus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensorial loss with pin prick test		intraoperative 5 th minute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

surgery with spinal anesthesia

Exclusion Criteria:

heart failure
coronary artery disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

patients who undergoes surgery with spinal anesthesia

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
dilek yazıcıoğlu, M.D.	M.D.	Study Chair

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17509868	Background	Hoppe J, Popham P. Complete failure of spinal anaesthesia in obstetrics. Int J Obstet Anesth. 2007 Jul;16(3):250-5. doi: 10.1016/j.ijoa.2006.12.005. Epub 2007 May 16.

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

ID	Term
D000765	Anesthesia, Conduction
D000758	Anesthesia
D000760	Anesthesia and Analgesia