Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001042336
Ethics application status
Approved
Date submitted
29/05/2017
Date registered
17/07/2017
Date last updated
17/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of anesthesia type on intraocular pressure for lumbar surgery operations.
Scientific title
The effect of spinal and general anesthesia on intraocular pressure for lumbar discectomy surgery
Secondary ID [1] 292068 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients who have herniated lomber disc 303475 0
Condition category
Condition code
Anaesthesiology 302886 302886 0 0
Anaesthetics
Musculoskeletal 303080 303080 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients divided two groups. Anesthesia types are differnt for groups.
1. Group: Spinal anesthesia with 15 mg bupivacaine ( given to cerebrospinal fluid) before procedure.
2. Group General anesthesia with 2 mcg/kg fentanyl intravenous.,, 2 mg/kg propofol intravenous.and 0.6 mg / kg rocuronium intravenous induction doses, and anesthesia maintenance with 2 % sevoflurane inhalation until completion of procedure.
Intervention code [1] 298204 0
Treatment: Drugs
Comparator / control treatment
Comparing spinal and general anesthesia
Control group
Active

Outcomes
Primary outcome [1] 302276 0
intraocular pressure measurements with portable tonometer (for intraocular pressure measurement)
Timepoint [1] 302276 0
preoperative time ( basal ) , 10 minutes after anesthesia application, 10 minutes after prone positioning, at the end of the operation are four timepoints for intraocular pressure measurements.
Secondary outcome [1] 335342 0
visual disturbance after operation
Timepoint [1] 335342 0
1. day after surgery with asking patients verbally

Eligibility
Key inclusion criteria
1) Patients > 18 years old
2) Patients who undergo lumbar discectomy surgery
3) ASA I-III physical status patients
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients who have any eye illness
2) Any operation from eyes
3) Beta blocker drug usage
4) Known local anesthetic allergy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2017
Date of last participant enrolment
Anticipated
30/08/2017
Actual
Date of last data collection
Anticipated
31/08/2017
Actual
Sample size
Target
40
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 8929 0
Turkey
State/province [1] 8929 0
KONYA

Funding & Sponsors
Funding source category [1] 296600 0
University
Name [1] 296600 0
Baskent University
Country [1] 296600 0
Turkey
Primary sponsor type
University
Name
Baskent University
Address
Taskent Caddesi (Eski 1. Cadde) 77. Sokak (Eski 16. Sokak) No:11 06490 Bahcelievler / ANKARA
Country
Turkey
Secondary sponsor category [1] 295556 0
None
Name [1] 295556 0
Address [1] 295556 0
Country [1] 295556 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297827 0
Baskent University Clinical Research Ethical Committee
Ethics committee address [1] 297827 0
Taskent Caddesi 77. Sokak No:11 06490 Bahcelievler Cankaya Ankara
Ethics committee country [1] 297827 0
Turkey
Date submitted for ethics approval [1] 297827 0
11/04/2013
Approval date [1] 297827 0
12/11/2013
Ethics approval number [1] 297827 0
KA 13/103

Summary
Brief summary
Prone position can increase intraocuar pressure especially for lumbar surgery. Many studies evaluated intraocular pressure in patients under general anesthesia. But there is not a study examinig patient under spinal anesthesia. In this study our aim is to investigate effects of spinal and general anesthesia on lumbar discectomy patients in prone position.
40 ASA I-III patients over 18 years old who undergo lumbar disc surgery patients will paritcipate study. Eye illness, eye surgery history, beta blocker drug usage, local anesthetic allergy are exclusion criterias. we record heigt, weight, hypertension or diabetes mellitus existence.
We randomize patients in two groups. 1) Spinal anesthesia group 2) General anesthesia group
We both measure intraocular pressure of both eyes each group when patients are supin position with portable tonometer. After that, we will perform spinal anesthesia with 15 mg hiperbaric bupivacaine from L3-4 lumbar interspace for spinal group and general anesthesia induction with fentanyl 2mcg/kg i.v., propofol 2 mg /kg i.v. and rocuronium 0.6 mg/kg for general anesthesia group patients and maintain anesthesia with 2% sevoflurane i.v.. We measure intraocular pressure after anesthesia at 10th minute, 10 minutes after prone positioning and at the end of the operation at prone position. We will record mean arterial pressure, at intraocular pressure measurements time, We will ask patients at first postoperative day if they have any visual disturbances.
We compare the results of intraocular pressures and evaluate with appropriate statistical methods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75206 0
Mr Huseyin Ulas Pinar
Address 75206 0
Hocacihan mah. saray cad No:1 Selcuklu/ Konya postal Code: 42080
Country 75206 0
Turkey
Phone 75206 0
+903322570606
Fax 75206 0
Email 75206 0
[email protected]
Contact person for public queries
Name 75207 0
Mr Huseyin Ulas Pinar
Address 75207 0
Hocacihan mah. saray cad No:1 Selcuklu/ Konya Postal Code: 42080
Country 75207 0
Turkey
Phone 75207 0
+903322570606
Fax 75207 0
Email 75207 0
[email protected]
Contact person for scientific queries
Name 75208 0
Mr Huseyin Ulas Pinar
Address 75208 0
Hocacihan mah. saray cad No:1 Selcuklu/ Konya
Postal Code : 42080
Country 75208 0
Turkey
Phone 75208 0
+903322570606
Fax 75208 0
Email 75208 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
SourceTitleYear of PublicationDOI
EmbaseThe effect of spinal versus general anesthesia on intraocular pressure in lumbar disc surgery in the prone position: A randomized, controlled clinical trial.2018https://dx.doi.org/10.1016/j.jclinane.2018.01.026
N.B. These documents automatically identified may not have been verified by the study sponsor.