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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007590 |
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Date of registration:
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08/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intraocular pressure during neurosurgical procedures in context of the head position
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Scientific title:
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Intraocular pressure during neurosurgical procedures in context of the head position |
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Date of first enrolment:
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24/04/2015 |
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Target sample size:
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64 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00007590 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: basic science
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Patrick
Czorlich |
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Address:
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Martinistr. 52
20246
Hamburg
Germany |
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Telephone:
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040-7410-53750 |
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Email:
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p.czorlich@uke.de |
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Affiliation:
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Universitätsklinikum Hamburg-EppendorfKlinik und Poliklinik für Neurochirurgie |
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Name:
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Patrick
Czorlich |
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Address:
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Martinistr. 52
20246
Hamburg
Germany |
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Telephone:
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040-7410-53750 |
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Email:
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p.czorlich@uke.de |
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Affiliation:
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Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für Neurochirurgie |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Proof of pathology within in the fossa posterior with anterior-posterior head positioning or maximum turned head or spinal intradural procedures or spinal procedures without opening of the Dura mater in anterior-posterior positioning.
2. Written informed consent of the patient.
3. Expected compliance of the patient.
Exclusion criteria: 1. Evident or suspected pregnanct.
2. Visual disturbance of less than 0.05. Disturbance of eye motality due to pathology in the fossa posterior is no exclusion criteria.
3. Any ophthalmologic disease, especially any kind of glaucoma or astigmatism with more ± 8 dpt.
4. Any kind of known allergic reaction to local anaesthesia or mydriatic medication.
5. Known Diabetes melltius, peripheral vascular diseases or Body-Mass-Index >30.
6. Participation in any other interventional study.
7. Any diesease that interacts with this study.
8. Any other aspect that denies a participation in this study.
9. Any kind of emergency procedure with no time to considerate if the patient want to participate in this study.
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Intraoperative intraocular pressure
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Intervention(s)
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Group 1: Spinal intradural procedures in prone position with anterior-posterior positioning of the head. In all patients pre- and postoperative ophthalmological examination will be performed. Beyond that pre-, intra- and postoperative intraocular pressure will be recorded.
Group 2: Fossa posterior procedures in prone position with anterior-posterior positioning of the head. In all patients pre- and postoperative ophthalmological examination will be performed. Beyond that pre-, intra- and postoperative intraocular pressure will be recorded.
Group 3: Fossa posterior procedures in semiprone position with maximum rotation of the head. In all patients pre- and postoperative ophthalmological examination will be performed. Beyond that pre-, intra- and postoperative intraocular pressure will be recorded.
Group 4: Controlgroup: Spine procedures in prone position with anterior-posterior positioning of the head and no loss of cerebrospinal fluid. In all patients pre- and postoperative ophthalmological examination will be performed. Beyond that pre-, intra- and postoperative intraocular pressure will be recorded.
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Primary Outcome(s)
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Measurement and description of the intraocular pressure, measured with a hand-held applanation tonometer (Tonopen XL), prior to intubation, after intubation, after final positioning for the procedure, after positioning every 30min until opening of the Dura mater, after losing of cerebrospinal fluid, every 30min to the end of the procedure, before returning to supine position and after extubation.
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Secondary Outcome(s)
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Complete ophthalmological examination one day prior to procedure and 5 to 7 days after the operation including measurement of intraocular pressure by tonometry after Goldman and visual testing.
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Source(s) of Monetary Support
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Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für Neurochirurgie
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Ethics review
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Status: Approved
Approval date: 21/10/2014
Contact:
ethik@aekhh.de
Ethik-Kommission der Ärztekammer Hamburg
+49-40-2022990
ethik@aekhh.de
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