Intraocular PressureNCT02061644
Spinal Anesthesia - Intraocular Pressure
A study testing Spinal anesthesia in people with Intraocular Pressure, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
We aim to investigate the effect of spinal anesthesia on intraocular pressure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- Spinal anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2014to Apr 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients having general surgery operations under umbilicus
- patients of American Society of Anesthesiologists (ASA) status I-II
Who cannot join
- patients denying spinal anesthesia
- contraindications for spinal anesthesia
- eye diseases
- hypertension
- ASA status III or more
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adiyaman University Research Hospital
Adıyaman, 02000
About this study
Official title: Intraocular Pressure Changes After Spinal Anesthesia: Acute and Subacute Effects
We aim to investigate the effect of spinal anesthesia on intraocular pressure.
Read the detailed description
Spinal anesthesia provides adequate anesthetic conditions for many operations. These operations include orthopedic, urological, gynecological and many general surgery operations. Although few, side effects of the procedure and its effects on body are well known. However, there is inadequate knowledge about the effects of spinal anesthesia on pressure changes in the eyes. These pressure changes in eyes can result in some detriments. Elevated pressures in the eyes can result in disease known as glaucoma, that makes hazard to eyes. Decreased eye pressures can also result in some eye detriments.
We aimed to investigate the effects of spinal anesthesia procedure on eye (intraocular) pressure changes.
- Conditions
- Intraocular Pressure
- Being tested
- Spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesiaOther
Routine spinal anesthesia procedure will be made to the patients for surgical anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Spinal | Experimental | Spinal anesthesia for surgical procedure will be applied to the patients. Intraocular pressures will be measured before and after the procedure. Receives: Other: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the patients with changed intraocular pressure
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruslan Abdullayev, Adiyaman University Research Hospital
- Investigators
- Ruslan Abdullayev, Dr, Principal investigator, Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation, Adiyaman City, Turkey.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061644
- Sponsor's protocol ID
- Spinal-IOP
- Status last verified
- Apr 2014
- First submitted
- 10 Feb 2014
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure Changes After Spinal Anesthesia: Acute and Subacute Effects
- ClinicalTrials.gov ID
- NCT02061644
- Acronym / sponsor ID
- Spinal-IOP
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 13 Feb 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.
We aim to investigate the effect of spinal anesthesia on intraocular pressure.
Detailed description
Spinal anesthesia provides adequate anesthetic conditions for many operations. These operations include orthopedic, urological, gynecological and many general surgery operations. Although few, side effects of the procedure and its effects on body are well known. However, there is inadequate knowledge about the effects of spinal anesthesia on pressure changes in the eyes. These pressure changes in eyes can result in some detriments. Elevated pressures in the eyes can result in disease known as glaucoma, that makes hazard to eyes. Decreased eye pressures can also result in some eye detriments.
We aimed to investigate the effects of spinal anesthesia procedure on eye (intraocular) pressure changes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal | Experimental | Other: Spinal anesthesiaSpinal anesthesia for surgical procedure will be applied to the patients. Intraocular pressures will be measured before and after the procedure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients having general surgery operations under umbilicus
- patients of American Society of Anesthesiologists (ASA) status I-II
Key exclusion criteria (5 listed)
- patients denying spinal anesthesia
- contraindications for spinal anesthesia
- eye diseases
- hypertension
- ASA status III or more
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 anesthesiaRoutine spinal anesthesia procedure will be made to the patients for surgical anesthesia. | Other | Spinal |
Primary outcome
Number of the patients with changed intraocular pressure
Time frame: One month
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 7 Apr 2014.
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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.
Ruslan Abdullayev, Dr principal investigator
Adiyaman University Research Hospital, Department of Anesthesiology and Reanimation, Adiyaman City, Turkey.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia in people with Intraocular Pressure, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of the patients with changed intraocular pressure (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2014.