Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001359729
Ethics application status
Approved
Date submitted
6/12/2013
Date registered
12/12/2013
Date last updated
12/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of intraocular pressure changes during anesthesia
Scientific title
"Intraocular pressure changes during sevoflurane and desflurane anesthesia in patients requiring non-ophthalmic surgery: randomised, controlled trial"
Secondary ID [1] 283737 0
none
Universal Trial Number (UTN)
U1111-1151-0700
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ASA 1-2, patients scheduled for general anesthesia in non-ophtalmic surgery in supine position 290672 0
Intraocular pressure changes 290673 0
Condition category
Condition code
Anaesthesiology 291043 291043 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Desflurane is the intervention of the study. It is very frequently used inhalant anesthetic. It will be inhaled approxiamately 1 hour for the duration of the surgical procedure at 1 Minimum alveolar concentration (MAC) .
Intervention code [1] 288400 0
Treatment: Drugs
Comparator / control treatment
Sevoflurane is the control treatment. Itis an inhalant anesthetic.It will be inhaled approxiamately 1 hour for the duration of the surgical procedure at 1 Minimum alveolar concentration (MAC) .
Control group
Active

Outcomes
Primary outcome [1] 291033 0
Evaluation of intraocular pressure changes with sevoflurane and desflurane with perkins tonometer.
Timepoint [1] 291033 0
Before operation begins, after induction, after intubation, during the surgery at every 15 minutes. after the extubation.
Secondary outcome [1] 305868 0
any eye problems after surgery (If patient complaint any eye problems such as pain or changes in seeing; ophtalmology consultation will be done)
Timepoint [1] 305868 0
24 hours after completion of the surgery

Eligibility
Key inclusion criteria
Without any eye disorder, not using eye medications, ASA 1-2, scheduled for non-ophtalmic surgery general anesthesia. Mallampathy score less than 3.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
DM, HT, Cardiovascular problems,known eye disorders or using some eye medicatons,refusal of the study, immunulugic disease, rheumatologic disease history, laparoscopic procedures, hard to ventilate and intubate, succinylcholine use during induction of anesthesia

Study design
Purpose of the study
Diagnosis
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
7/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 5667 0
Turkey
State/province [1] 5667 0
KONYA

Funding & Sponsors
Funding source category [1] 288389 0
University
Name [1] 288389 0
Meram Medical School
Country [1] 288389 0
Turkey
Primary sponsor type
University
Name
Meram Medical School
Address
Meram Medical School Anesthesiology DPT, Akyokus Street, Meram 42080 KONYA
Country
Turkey
Secondary sponsor category [1] 287091 0
Individual
Name [1] 287091 0
Tuba Berra Saritas
Address [1] 287091 0
Meram Medical School Anesthesiology DPT, Akyokus Street, Meram 42080 KONYA
Country [1] 287091 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290275 0
Meram Medical School Ethics Committee
Ethics committee address [1] 290275 0
Meram Medical School Anesthesiology DPT, Akyokus Street, Meram 42080 KONYA
Ethics committee country [1] 290275 0
Turkey
Date submitted for ethics approval [1] 290275 0
Approval date [1] 290275 0
29/05/2009
Ethics approval number [1] 290275 0
2009-247

Summary
Brief summary
American Society of Anesthesiologists Classification (ASA) 1-2 patients scheduled for non-ophtalmic surgery under general anesthesia included to the study. Patients are allocated in one of the groups either sevoflurane or desflurane. Intraocular pressure changes measured with perkin's tonometer before surgery, after induction, after intubation at every 15 min during the surgery, after extubation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44602 0
Dr Tuba Berra Saritas
Address 44602 0
Meram Medical School Anesthesiology DPT, Akyokus Street, Meram 42080 KONYA
Country 44602 0
Turkey
Phone 44602 0
+905443664244
Fax 44602 0
Email 44602 0
[email protected]
Contact person for public queries
Name 44603 0
Dr Tuba Berra Saritas
Address 44603 0
Meram Medical School Anesthesiology DPT, Akyokus Street, Meram 42080 KONYA
Country 44603 0
Turkey
Phone 44603 0
+905443664244
Fax 44603 0
Email 44603 0
[email protected]
Contact person for scientific queries
Name 44604 0
Dr Tuba Berra Saritas
Address 44604 0
Meram Medical School Anesthesiology DPT, Akyokus Street, Meram 42080 KONYA
Country 44604 0
Turkey
Phone 44604 0
905443664244
Fax 44604 0
Email 44604 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.