UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050492 |
|---|---|
| Receipt number | R000057474 |
| Scientific Title | Evaluation of intraocular pressure changes and ocular complications during prone position surgery under general anesthesia |
| Date of disclosure of the study information | 2023/03/05 |
| Last modified on | 2023/03/05 12:26:27 |
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Basic information
Public title
Changing of intraocular pressure(IOP)during prone position in spine surgery
Acronym
Changing of intraocular pressure(IOP)during prone position in spine surgery
Scientific Title
Evaluation of intraocular pressure changes and ocular complications during prone position surgery under general anesthesia
Scientific Title:Acronym
Evaluation of intraocular pressure changes and ocular complications during prone position surgery under general anesthesia
Region
| Japan |
Condition
Condition
spine surgery/adult healthy(ASA I or II)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of intraocular pressure, eyesight, and fundus examination are performed before, during, and after surgery for patients undergoing surgery in the prone position.
Exploring the relationship between intraocular pressure and ocular complications.
Basic objectives2
Others
Basic objectives -Others
Presence or absence of postoperative eye complications
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The day before surgery, an ophthalmologist examine the patient's vision, intraocular pressure, and fundus.
On the day of surgery, the anesthesiologist measure intraocular pressure at after intubation, 5 minutes after prone position, 1 hour, 2 hours after intubation, the end of surgery, and reterning to the supine position.
In patients who underwent laparotomy in the supine position as a control, intraocular pressure was measured on the day ofsurgery at intubation, 1 and 2 hours after intubation, after wound closure, and at the end of surgery.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Surgery in the prone position under general anesthesia (surgery in general anesthesiology without the use of a laparoscopic supine position, and Spinal surgery in supine position under general anesthesia as a control)
Adults(ASA I or II) who consented to the study
Key exclusion criteria
Patients with corneal disease, glaucoma, or diabetic retinopathy (Fukuda classification more than 1)
Cases determined to be inappropriate in the preoperative examination
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | tsuya |
| Middle name | |
| Last name | Ikeda |
Organization
KItasato University School of Medical
Division name
Ophthalmology
Zip code
252-0375
Address
1-15-1 Kitasato Sagamihara city Minamiku Kanagawa, Japan
TEL
0427788430
t-ikeda@kitasaato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ikeda |
Organization
KItasato University School of Medical
Division name
Ophthalmology
Zip code
252 0375
Address
1-15-1 Kitasato Sagamihara city Minamiku Kanagawa, Japan
TEL
0427788111
Homepage URL
t-ikeda@kitasaato-u.ac.jp
Sponsor or person
Institute
Tetsuya Ikeda
Kitasato University School of Medicine
1-15-1 Kitasato Sagamihara city Minamiku Kanagawa, Japan
Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Office, Kitasato University School of Medicine
Address
1-15-1 Kitasato Sagamihara city Minamiku Kanagawa, Japan
Tel
0427788111
ririb@med.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
This study protocol is not available to the public.
Publication of results
Unpublished
Result
URL related to results and publications
This study result is not available to the public.
Number of participants that the trial has enrolled
29
Results
Intraocular pressure rise after prone position to 1 hour, and gradually increase to wound closure, and decrease after returning to the supine. Laparotomy with supine position was no significant difference at all points. No patients had visual impairment. No risk factors did not detected. There was no significant deference in intraocular pressure when comparing the head device of horseshoe and pin.
Results date posted
| 2023 | Year | 03 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Recently, visual impairment including blindness after prone position surgery has been reported.
Prone surgery may lead to angle closure, acute closure glaucoma, ischemic optic neuritis, and central retinal artery occlusion.
It is suspected that prolonged prone position causes increase of intraocular pressure by angle occlusion, and also cause bulockade of feeding vessels.
However, there have been no reports examine visual impairment in the prone position by comoared the angle, visual acuity, and intraocular pressure before, during, and after prone surgery.
Therefore, in this study, we will compare intraocular pressure, visual acuity, and fundus before, during, and after surgery in prone position surgery to investigate the cause of visual impairment.
Participant flow
Patients scheduled for prone spine surgery on thursday will be hospitalized on wednesday because of circumstances of the anesthesiologist and ophthalmology department.
Admitted to the hospital at 10am on Wednesday. For adult patients without severe complication, Takenami explains, and obtained consent.
When consent was obtained, Takenami contact to ophthalmologic outpatient department, and after that, the patient visit there.
After absence of eye problem is confirmed by ophthalmologic medical record, the patient was measured intarocular pressure during operation on the following day.
Adverse events
No adverse events were identified in all patients
Outcome measures
*Preoperative Ophthalmologic examination
eye sight, angle, intraocular pressure, fundus
*intraoperative examination
Before each masurement of intraocular pressure by tonometry (Tonopen), eyedrop must use.
Measurement points: after intubation, 5 minutes after prone position, 1 hour after prone position, 2 hours after prone position, at wound closure , at 5 minutes after returning to the supine position
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In Preoperative ophthalmic outpatient measurement, The IOP measured in the supine position was significantly higher than that in the sitting position.
In the operative day, the intraocular pressure (IOP)at the time of intubation was used as the reference value during surgery. The intraocular pressure rises sharply from immediately after prone position to 1 hour, after that, it gradually increases with time, and became highest at wound closure. Therefore, the IOP at immediately after returning to the supine position from prone position did not significantly decrease compared to the reference value, but significantly decrease compared to the time of wound closure. On the other hand, laparotomy in which the operation was performed in the supine position, the intraocular pressure was the highest at the time of intubation, and there was no significant difference compared with the baseline value at all subsequent measurement points.
The normal intraocular pressure value is less than 20 mmHg, but more than 40mmHg in 7 patients, more than 30mmHg in 18 patients, respectively. The highest intraocular pressure value was 55.4 mmHg. However, no patients had visual impairment.
In addition, as a result of examining the risk factors for increasing IOP, angle angle, diabetes, hypertension, age, BMI, amounts of vasopressors, and infusion volume were not risk factors.
Furthermore, even in the same prone position spine surgery, when comparing the head fixative devices in the prone position (horseshoe vs pin fixation), the horseshoe device showed to tends to have a slightly higher intraocular pressure. However, there was no difference in intraocular pressure
Management information
Registered date
| 2023 | Year | 03 | Month | 05 | Day |
Last modified on
| 2023 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057474
