Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000143325
Ethics application status
Approved
Date submitted
29/12/2016
Date registered
25/01/2017
Date last updated
25/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The incidence of intraoperative awareness during general anesthesia in Turkey
Scientific title
The incidence of intraoperative awareness during general anesthesia: A multicenter Turkey study
Secondary ID [1] 290817 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anesthesia 301483 0
Intraoperative awareness 301484 0
Condition category
Condition code
Anaesthesiology 301188 301188 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be observed for anesthesia periods and awareness under anesthesia. This process will last for 1 month after anesthesia.
Participants will be simply interviewed at 24 hours and 28-30 days after their operation to assess for awareness under anaesthesia.
Intervention code [1] 296737 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300612 0
Incidence of intraoperative awareness
Timepoint [1] 300612 0
Patients will be interviewed first within 24 hours after operation and secondly 28-30 days after operation
Secondary outcome [1] 330411 0
Non
Timepoint [1] 330411 0
Non

Eligibility
Key inclusion criteria
Aged >18 yr,
apparently normal mental status
ability to provide informed consent
Patients to undergo general anesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they will not expected to survive,
transferred directly to the intensive care unit (ICU),
can not speak Turkish,
has dementia,
has previous stroke history with neurological deficit
has abnormal mental status that precluded answering the questions.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment outside Australia
Country [1] 8532 0
Turkey
State/province [1] 8532 0
Konya, Isparta, Antalya, Bursa, Ordu

Funding & Sponsors
Funding source category [1] 295243 0
Hospital
Name [1] 295243 0
Konya Training and Research Hospital
Country [1] 295243 0
Turkey
Primary sponsor type
Hospital
Name
Konya Training and Research Hospital
Address
Konya Training and Research Hospital, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Meram KONYA, Postcode:42090
Country
Turkey
Secondary sponsor category [1] 294070 0
None
Name [1] 294070 0
Address [1] 294070 0
Country [1] 294070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296582 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 296582 0
Ethics committee country [1] 296582 0
Turkey
Date submitted for ethics approval [1] 296582 0
12/12/2016
Approval date [1] 296582 0
16/12/2016
Ethics approval number [1] 296582 0
2016/760

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71366 0
Dr Mehmet SARGIN
Address 71366 0
Isparta State Hospital, Doganci Mahallesi, Yokusbasi Sokak No:34, 32100 Isparta
Country 71366 0
Turkey
Phone 71366 0
+905322662766
Fax 71366 0
Email 71366 0
[email protected]
Contact person for public queries
Name 71367 0
Mehmet SARGIN
Address 71367 0
Isparta State Hospital, Doganci Mahallesi, Yokusbasi Sokak No:34, 32100 Isparta
Country 71367 0
Turkey
Phone 71367 0
+905322662766
Fax 71367 0
Email 71367 0
[email protected]
Contact person for scientific queries
Name 71368 0
Mehmet SARGIN
Address 71368 0
Isparta State Hospital, Doganci Mahallesi, Yokusbasi Sokak No:34, 32100 Isparta
Country 71368 0
Turkey
Phone 71368 0
+905322662766
Fax 71368 0
Email 71368 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.