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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
Patient registry
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

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).

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
Both males and females
Can healthy volunteers participate?
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
Natural history
Defined population
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 8765 0
State/province [1] 8765 0

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

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 297283 0
Approval date [1] 297283 0
Ethics approval number [1] 297283 0

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

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
Phone 73570 0
Fax 73570 0
Email 73570 0
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
Phone 73571 0
Fax 73571 0
Email 73571 0
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
Phone 73572 0
Fax 73572 0
Email 73572 0

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