Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000362796
Ethics application status
Approved
Date submitted
6/03/2013
Date registered
5/04/2013
Date last updated
30/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of anesthesia type on cognitive functions
Scientific title
The comparison of incidence of postoperative cognitive disorders after intravenous and inhalational anesthesia in the middle age population
Secondary ID [1] 282079 0
None
Universal Trial Number (UTN)
U1111-1140-1011
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative cognitive dysfunction 288573 0
Condition category
Condition code
Anaesthesiology 288907 288907 0 0
Anaesthetics
Mental Health 288908 288908 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total intravenous anesthesia - maintained by propofol infusion according to Roberts dosing scheme, adjusted by Bispectral index. Sufentanil (approx. 0,3 mcg/kg) will be used as analgetic component and rocuronium (0,6 mg/kg) for muscle relaxation. Mixture of air and oxygen for ventilation. Approx. duration of anesthesia 60 min.
Intervention code [1] 286679 0
Treatment: Drugs
Comparator / control treatment
Inhalational anesthesia - sevoflurane in concentration 1,0 MAC with age correction, in air and oxygen mixture, adjusted by Bispectral index. Sufentanil (approx. 0,3 mcg/kg) will be used as analgetic component and rocuronium (0,6 mg/kg) for muscle relaxation. Mixture of air and oxygen for ventilation. Approx. duration of anesthesia 60 min.
Control group
Active

Outcomes
Primary outcome [1] 289034 0
difference in postoperative psychometric test scoring (Digit Span Backward test, Letter Naming Sequencing test, Digit Span Forward test, Trail Making test, Mental Control test, Stroop test, Verbal fluency)
Timepoint [1] 289034 0
preoperative, day 1, 7, 40 after anesthesia
Primary outcome [2] 289035 0
difference in electrophysiologic examination results (Event-related potentials – Mismatch negativity and P3 component analysis)
Timepoint [2] 289035 0
preoperative, day 1, 7, 40 after anesthesia
Secondary outcome [1] 301612 0
postoperative pain measured by visual analogue scale
Timepoint [1] 301612 0
day 1 after anesthesia
Secondary outcome [2] 301762 0
presence of postoperative nausea and vomiting
Timepoint [2] 301762 0
day 1 after anesthesia

Eligibility
Key inclusion criteria
patients undergoing elective resection of intervertebral disc herniation
given and signed informed consent
Czech as the native language
finished high school
Minimum age
40 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Abnormal results of preoperative neuropsychological and electrophysiological tests
Disease of central nervous system
Addiction (also in history)
Psychiatric disease, use of psychiatric medication
Sleep apnoea syndrome
Perception disorder
Allergy or intolerance of drugs used for anesthesia

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)
Patients undergoing elective intervertebral herniation resection will be deemed eligible for inclusion. Depending on free capacity of electrophysiology lab (which performs pre- and postoperative examination), during routine preanesthesia visit, patients meeting inclusion and exclusion criteria will be informed about the possibility to participate in the study. Informed consent will be obtained.
Group of included patients will be randomized in 1:1 proportion (intravenous/inhalational anesthesia). Randomization will be performed just before anesthesia by the treating anesthesiologist - sealed envelopes technique.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sealed envelopes technique with the simple urn randomization method will be used to randomly allocate patients into the intravenous and inhalational arm. Equal randomization in proportion 1:1 will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/10/2012
Actual
4/10/2012
Date of last participant enrolment
Anticipated
31/12/2014
Actual
9/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 4900 0
Czech Republic
State/province [1] 4900 0

Funding & Sponsors
Funding source category [1] 286857 0
University
Name [1] 286857 0
Charles University Research Fund (project number P36)
Country [1] 286857 0
Czech Republic
Primary sponsor type
University
Name
Dpt. of Anesthesia and Intensive Care of the Faculty of Medicine Plzen - Charles University Prague
Address
The University hospital and The Faculty of Medicine in Plzen
Husova 3
Plzen
30605
Country
Czech Republic
Secondary sponsor category [1] 285646 0
Individual
Name [1] 285646 0
Jakub Kletecka, MD
Address [1] 285646 0
Dpt. of Anesthesia and Intensive Care
The University hospital and The Faculty of Medicine in Plzen
Husova 3
Plzen
30605
Country [1] 285646 0
Czech Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288917 0
Local ethics committee of the Charles University hospital in Plzen
Ethics committee address [1] 288917 0
Charles University hospital in Plzen
E.Benese 13
Plzen
305 99
Ethics committee country [1] 288917 0
Czech Republic
Date submitted for ethics approval [1] 288917 0
Approval date [1] 288917 0
11/07/2012
Ethics approval number [1] 288917 0

Summary
Brief summary
Aim of the study is to diagnose and compare the incidence of postoperative cognitive dysfunction after two commonly used types of general anesthesia – inhalational and intravenous - in the healthy middle age population. Combination of standardized psychometric tests and electophysiological examination will be used for detection of cognitive disorder at different time intervals after the operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38334 0
Dr Irena Holeckova, PhD
Address 38334 0
Dpt. of Neurosurgery
The University hospital and The Faculty of Medicine in Plzen Husova 3
30605 Plzen
Country 38334 0
Czech Republic
Phone 38334 0
+420377104371
Fax 38334 0
Email 38334 0
[email protected]
Contact person for public queries
Name 38335 0
Dr Jakub Kletecka
Address 38335 0
Dpt. of Anesthesia and Intensive Care
The University hospital and The Faculty of Medicine in Plzen Husova 3
30605 Plzen
Country 38335 0
Czech Republic
Phone 38335 0
+420377104381
Fax 38335 0
Email 38335 0
[email protected]
Contact person for scientific queries
Name 38336 0
A/Prof Ivan Chytra, CSc.
Address 38336 0
Dpt. of Anesthesia and Intensive Care
The University hospital and The Faculty of Medicine in Plzen Husova 3
30605 Plzen
Country 38336 0
Czech Republic
Phone 38336 0
+420377104381
Fax 38336 0
Email 38336 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
EmbasePropofol versus sevoflurane anaesthesia: effect on cognitive decline and event-related potentials.2019https://dx.doi.org/10.1007/s10877-018-0213-5
EmbaseCognitive impairment measured by event-related potentials during early and late postoperative period following intravenous or inhalation anaesthesia.2018https://dx.doi.org/10.1016/j.clinph.2017.10.038
N.B. These documents automatically identified may not have been verified by the study sponsor.