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Trial registered on ANZCTR


Registration number
ACTRN12617000676314
Ethics application status
Approved
Date submitted
24/03/2017
Date registered
11/05/2017
Date last updated
11/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
spinal anesthesia decreases ocular pressure in patients with leg surgery
Scientific title
The Effects Of Tourniquet On Intraocular Pressure During Lower Extremity Surgery Under Spinal Anesthesia
Secondary ID [1] 291532 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
leg pathologies 302626 0
intraocular pressure 302627 0
Condition category
Condition code
Anaesthesiology 302147 302147 0 0
Other anaesthesiology
Eye 302243 302243 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
measurement of intraocular pressure in patients who went on lower extremity surgery under spinal anesthesia (with or without tourniquet),Tuorniquet were used in 30 patients and were not used in other 30 patients.Participants observed once immediately prior to anaesthesia, and again 3 different times during surgery and at the end of surgery.The use of tourniquet was decided by surgeon.
Intervention code [1] 297603 0
Not applicable
Comparator / control treatment
Comparison of intraocular pressure measurement in patients with or without tourniquet
Control group
Active

Outcomes
Primary outcome [1] 301573 0
Change in intraocular pressure(IOP) with spinal anesthesia with or without tourniquet was assessed with tonometer(Reichert Tono-Pen AVIA-Registered Trademark' Applanation Tonometer).
Timepoint [1] 301573 0
end of surgery
Secondary outcome [1] 333122 0
effect of tourniquet on intraocular pressure during spinal anesthesia, intraocular pressure was measured with contact tonometer, patients were informed before the measurement.
Timepoint [1] 333122 0
IOP was recorded 5 minutes before spinal anesthesia (T1) , 5 minutes after spinal anesthesia (T2), when operation started (T3)(5 minutes after tourniquet inflated in tourniquet group and 5 minutes after T2 in group without tourniquet) and at the end of the surgery (T4).

Eligibility
Key inclusion criteria
After approval by Ethics Committee and written informed consent from the patients,
ASA physical status I-II patients
Aged 18-65 years
Elective lower extremity surgery were included in the study
patients who were operated under spinal anesthesia
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic diseases except regular hypertension
Known allergies to any anesthetic drugs used in the study
Eye disease or surgery in the medical history
Any contrendications for spinal anesthesia
Estimated tourniquet time more 120 min

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
.Student T test was used for the normal ranged data
Mann Whitney U test was used for data that was except of the normal range.
Categorical data was compared with Chi-square test. p<0.05 was accepted as significant.Data was analyzed using SPSS 16 software.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8765 0
Turkey
State/province [1] 8765 0

Funding & Sponsors
Funding source category [1] 296021 0
University
Name [1] 296021 0
selcuk university hospital
Address [1] 296021 0
Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya
TURKEY
Country [1] 296021 0
Turkey
Primary sponsor type
Hospital
Name
selcuk university hospital
Address
Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya
TURKEY
Country
Turkey
Secondary sponsor category [1] 294911 0
Hospital
Name [1] 294911 0
selcuk university hospital
Address [1] 294911 0
Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya
TURKEY
Country [1] 294911 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297283 0
selcuk university hospital comitte of ethics
Ethics committee address [1] 297283 0
Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya
Ethics committee country [1] 297283 0
Turkey
Date submitted for ethics approval [1] 297283 0
31/07/2012
Approval date [1] 297283 0
09/08/2012
Ethics approval number [1] 297283 0
2012/34

Summary
Brief summary
Background: There are many factors which may effect intraocular pressure.Tourniquet, which is used in extremity surgery, also effect intraoculary pressure.There many studies about the effect of tourniquet on intraocular pressure, that were performed in patients went on general anesthesia.There was no study about the
effect of tourniquet on intraoculary pressure that was performed in patients who go on spinal anethesia.
Material and methods : Intraocular pressure was measured on patients who went on lower extremity surgery with or without tourniquet under spinal anesthesia.Measurements were performed before spinal anethesia, 5 minutes after spinal anethesia, 5 minutes after surgery started and at the end of the surgery.All measurements were performed in the supine position.Mean arterial blood pressure, heart rate, intraocular pressure and bleeding volumes were recorded.
Results: In both groups, 5 minutes after spinal anesthesia intraocular pressure measurements were lower than the baseline intraocular pressure measurements.However, the measurements which were performed after tourniquet
insufflation were higher than the baseline.
Conclusion:Intraocular pressure decreases in patient who went on spinal anesthesia but, tourquet insufflation increases intraocular pressure also in patients who went lower extremity surgery with tourniquet.
Trial website
Trial related presentations / publications
1.Hunt K , Bajekal K , Calder I , Meacher R , Eliahoo J , Acheson J F , Changes in Intraocular Pressure in Anesthetized Prone Patients , J Neurosurg Anesthesiol Volume 16, Number 4, October 2004

2. Bulut N G , Karaaslan K , Ozturan K E , Cakici H , Kocoglu H , The Effects of Tourniquet on Intraocular Pressure During Knee Surgery , M.E.J. Anesth 21 (1), 2011;93-97

3.Arai Y P, Ogata J, Matsumoto Y, Yonemura H, Kido K, Uchida T, Ueda W, Preoperative stellate ganglion blockade prevents tourniquet induced hypertension during general anesthesia, Acta Anaesthesiol Scand 2004; 48: 613—618

4. Jaen Diaz Ji , Cordero Garcia B , Lopez de Castro F , De Castro Mesa C , Castilla Lopez Madridejos F , Berciano Martinez F , Diurnal variability of intraocular pressure Arch Soc Esp Oftalmol 2007; 82: 675-680

5.Marcus D F , Krupin T , Podos S M , Becker B , The effect of exercise on intraoculer pressure ,
Investigative ophthalmology ,1970 oct 9:749-752

6. M.A. Moura, L.O.C. Rodrigues, Y. Waisberg, H.G. de Almeida, E. Silami Garcia
Effects of submaximal exercise with water ingestion on intraocular pressure in healthy human males
Brazilian Journal of Medical and Biological Research (2002) 35: 121-125

7.Brauner S C , Chen T C , Hutchinson B T , Chang M A , Pasquale L R , Grosskreutz C L ,
The Course of Glaucoma During Pregnancy A Retrospective Case Series ,
Arch Ophthalmol. 2006;124:1089-1094

8.Razeghinejad M R , Tak Yee Tania Tai , Fudemberg S J , Katz L J , Pregnancy and Glaucoma ,Survey of Ophthalmology volume 56 number 4 july–august 2011

9.Dumskyj M J , C J Mathias , Dore C J , Bleasdale-Barr K , Kohner E M , Postural variation in
Intraocular pressure in primary chronic autonomic failure J Neurol (2002) 249 : 712–718.

10.Grosso A , Scozzari G , Bert F , Mabilia M A , Siliquini R ,Morino M , Intraocular pressure
variation during colorectal laparoscopic surgery: standard pneumoperitoneum leads to reversible
elevation in intraocular pressure , Surgical Endoscopy 2013 Apr 3
Public notes

Contacts
Principal investigator
Name 73570 0
Dr eyup aydogan
Address 73570 0
konya training and research hospital , Hacisaban Mahallesi, Yeni Meram Cd. No:97, 42090 Meram/Konya
Country 73570 0
Turkey
Phone 73570 0
+903322210000-2250
Fax 73570 0
Email 73570 0
eypaydogan@hotmail.com
Contact person for public queries
Name 73571 0
Mrs inci kara
Address 73571 0
Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya
Country 73571 0
Turkey
Phone 73571 0
+903322415000
Fax 73571 0
Email 73571 0
incikara42@mynet.com
Contact person for scientific queries
Name 73572 0
Mrs jale bengi celik
Address 73572 0
Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya
Country 73572 0
Turkey
Phone 73572 0
+903322415000
Fax 73572 0
Email 73572 0
jalecelik42@mynet.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary