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NCT02294110 Clinical Trial

Effect of Diabetes Mellitus on Success of Spinal Anesthesia

Diabetes Mellitus Clinical Trial

Official title:
Phase IV Study of Diabetes Mellitus for Spinal Anesthesia Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02294110
Other study ID # DMSAFAILURE
Secondary ID
Status Completed
Phase N/A
First received October 12, 2014
Last updated August 4, 2015
Start date November 2014
Est. completion date December 2014

Study information
Verified date August 2015
Source Diskapi Yildirim Beyazit Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Drug and Medical Device Institution
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- surgery with spinal anesthesia

Exclusion Criteria:

- heart failure

- coronary artery disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• spinal anesthesia
non diabetes mellitus

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

References & Publications (1)

Hoppe J, Popham P. Complete failure of spinal anaesthesia in obstetrics. Int J Obstet Anesth. 2007 Jul;16(3):250-5. Epub 2007 May 16. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary sensorial loss with pin prick test intraoperative 5 th minute No
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