Intraocular pressure during neurosurgical procedures in context of the head position
Organizational Data
- DRKS-ID:
- DRKS00007590
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2014-12-08
- Last update in DRKS:
- 2022-11-21
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Postoperative vision disturbance or loss after spine operations is a rare but serious adverse event. Increase of intraocular pressure due to prone positioning is considered to be a risk factor. Visual disturbance or loss after neurosurgical procedures such as tumors in the cerebellum or fossa posterior, the head-neck are or within in the spinal cord are not documented. Losing of cerebrospinal fluid within these procedures might result in a decrease of the intraocular pressure. Aim of this study is to investigate the intraocular pressure during such procedures and to find out if the head positioning during the procedure has an influence on the intraocular pressure. Dependent on the results of this trial possibly new recommendations for the head positioning during neurosurgical interventions are available.
Brief summary in scientific language
Postoperative vision disturbance or loss after spine operations is a rare but serious adverse event. Increase of intraocular pressure due to prone positioning is considered to be a risk factor. Visual disturbance or loss after neurosurgical procedures within fossa posterior, the cranio-cervical junction or intradural spine procedures are not documented. Losing of cerebrospinal fluid within these procedures might result in a decrease of the intraocular pressure. Aim of this study is to investigate the intraocular pressure during such procedures and to find out if the head positioning during the procedure has an influence on the intraocular pressure. Dependent on the results of this trial possibly new recommendations for the head positioning during neurosurgical interventions are available.
Health condition or problem studied
- Free text:
- Intraoperative intraocular pressure
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
- Arm 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.
- Arm 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.
- Arm 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.
Endpoints
- Primary outcome:
- 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.
- Secondary outcome:
- 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.
Study Design
- Purpose:
- Basic research/physiological study
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Klinik und Poliklinik für Neurochirurgie Hamburg
Recruitment period and number of participants
- Planned study start date:
- 2015-01-02
- Actual study start date:
- 2015-04-24
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2017-10-12
- Target Sample Size:
- 64
- Final Sample Size:
- 64
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional 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.
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für NeurochirurgiePD Dr. med. Patrick CzorlichMartinistr. 5220246 HamburgGermany
- Telephone:
- 040-7410-53750
- Fax:
- 040-7410-58121
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für NeurochirurgiePD Dr. med. Patrick CzorlichMartinistr. 5220246 HamburgGermany
- Telephone:
- 040-7410-53750
- Fax:
- 040-7410-58121
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Contact for Public Queries
- Address:
- Universitätsklinikum Hamburg-EppendorfKlinik und Poliklinik für NeurochirurgiePD Dr. med. Patrick CzorlichMartinistr. 5220246 HamburgGermany
- Telephone:
- 040-7410-53750
- Fax:
- 040-7410-58121
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Principal Investigator
- Address:
- Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für NeurochirurgiePD Dr. med. Patrick CzorlichMartinistr. 5220246 HamburgGermany
- Telephone:
- 040-7410-53750
- Fax:
- 040-7410-58121
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für NeurochirurgieMartinistr. 5220246 HamburgGermany
- Telephone:
- 040-7410-53750
- Fax:
- 040-7410-58121
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Ärztekammer HamburgWeidestraße 122 b22083 HamburgGermany
- Telephone:
- +49-40-2022990
- Fax:
- +40-40-202299410
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-09-02
- Ethics committee number:
- PV4836
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-10-21
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Intraocular pressure during neurosurgical procedures in context of head position and loss of cerebrospinal fluid
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry