Diabetes MellitusNCT02294110
Effect of Diabetes Mellitus on Success of Spinal Anesthesia
An observational study of Diabetes Mellitus, run by Diskapi Yildirim Beyazit Education and Research Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- spinal anesthesia
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who undergoes surgery with spinal anesthesia
Who may be able to join
- surgery with spinal anesthesia
Who cannot join
- heart failure
- coronary artery disease
About this study
Official title: Phase IV Study of Diabetes Mellitus for Spinal Anesthesia Failure
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- spinal anesthesia
- Keywords
- failure, spinal anesthesia
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaOther
non diabetes mellitus
| Study group | Role | What they receive |
|---|---|---|
| diabetes mellitus | spinal anesthesia Receives: Other: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensorial loss with pin prick test
Measured: intraoperative 5 th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İBRAHİM ÖZTÜRK, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- dilek yazıcıoğlu, M.D., Study chair, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294110
- Sponsor's protocol ID
- DMSAFAILURE
- Status last verified
- Aug 2015
- First submitted
- 12 Oct 2014
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17509868
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Diabetes Mellitus for Spinal Anesthesia Failure
- ClinicalTrials.gov ID
- NCT02294110
- Acronym / sponsor ID
- DMSAFAILURE
- Conditions
- Diabetes Mellitus
- Keywords
- failure, spinal anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diabetes mellitus | – | Other: spinal anesthesiaspinal anesthesia |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who undergoes surgery with spinal anesthesia
Key inclusion criteria (1 listed)
- surgery with spinal anesthesia
Key exclusion criteria (2 listed)
- heart failure
- coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesianon diabetes mellitus | Other | diabetes mellitus |
Primary outcome
sensorial loss with pin prick test
Time frame: intraoperative 5 th minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
- Background: PubMed 17509868Hoppe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dilek yazıcıoğlu, M.D. study chair
M.D.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Diskapi Yildirim Beyazit Education and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensorial loss with pin prick test (time frame: intraoperative 5 th minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02294110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.