ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

leg pathologies

intraocular pressure

Condition category

Condition code

Anaesthesiology

Other anaesthesiology

Eye

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]

Not applicable

Comparator / control treatment

Comparison of intraocular pressure measurement in patients with or without tourniquet

Control group

Active

Outcomes

Primary outcome [1]

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]

end of surgery

Secondary outcome [1]

effect of tourniquet on intraocular pressure during spinal anesthesia, intraocular pressure was measured with contact tonometer, patients were informed before the measurement.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

selcuk university hospital

Address [1]

Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya
TURKEY

Country [1]

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]

Hospital

Name [1]

selcuk university hospital

Address [1]

Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya
TURKEY

Country [1]

Turkey

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

selcuk university hospital comitte of ethics

Ethics committee address [1]

Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

31/07/2012

Approval date [1]

09/08/2012

Ethics approval number [1]

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

Dr eyup aydogan

Address

konya training and research hospital , Hacisaban Mahallesi, Yeni Meram Cd. No:97, 42090 Meram/Konya

Country

Turkey

Phone

+903322210000-2250

Fax

eypaydogan@hotmail.com

Contact person for public queries

Name

inci kara

Address

Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya

Country

Turkey

Phone

+903322415000

Fax

incikara42@mynet.com

Contact person for scientific queries

Name

jale bengi celik

Address

Ardicli Mahallesi, Ismet Pasa Cd., 42250 Selcuklu/Konya

Country

Turkey

Phone

+903322415000

Fax

jalecelik42@mynet.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

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