Trial Review

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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
Sex
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
1/01/2013
Date of last participant enrolment
Anticipated
Actual
1/04/2013
Date of last data collection
Anticipated
Actual
1/04/2014
Sample size
Target
60
Accrual to date
Final
60
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
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
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 73571 0
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
[email protected]
Contact person for scientific queries
Name 73572 0
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.