NCT02294110

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

October 12, 2014

Last Update Submit

August 4, 2015

Conditions

Diabetes Mellitus

Keywords

failurespinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • sensorial loss with pin prick test

    intraoperative 5 th minute

Study Arms (1)

diabetes mellitus

spinal anesthesia

Other: spinal anesthesia

Interventions

spinal anesthesiaOTHER

non diabetes mellitus

diabetes mellitus

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients who undergoes surgery with spinal anesthesia

You may qualify if:

  • surgery with spinal anesthesia

You may not qualify if:

  • heart failure
  • coronary artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17509868BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • dilek yazıcıoğlu, M.D.

    M.D.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phase IV study of diabetes mellitus for spinal anesthesia failure

Study Record Dates

First Submitted

October 12, 2014

First Posted

November 19, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 5, 2015

Record last verified: 2015-08