Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000227493
Ethics application status
Approved
Date submitted
26/12/2015
Date registered
18/02/2016
Date last updated
18/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Low Dose Ketamine on Postoperative Cognitive Dysfunction in Geriatric Patients
Scientific title
Effect of Low Dose Ketamine on Postoperative Cognitive Dysfunction in Geriatric Patients Undergoing Abdominal Surgery
Secondary ID [1] 288220 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Dysfunction 297131 0
Abdominal surgery 297611 0
Condition category
Condition code
Anaesthesiology 297363 297363 0 0
Anaesthetics
Mental Health 297802 297802 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Effect of ketamine use on postoperative cognitive dysfunction

(ketamin will be used, iv, 0.5 mg/kg, 5 minutes before induction.)
Intervention code [1] 293513 0
Treatment: Drugs
Comparator / control treatment
Placebo ( 0.9 % NaCl) (2 ml)
Control group
Placebo

Outcomes
Primary outcome [1] 296916 0
Postoperative cognitive functions (assesse by mini mental state examination)
Timepoint [1] 296916 0
Postoperative 1st and 6th hours, cognitive functions will evaluate.
Secondary outcome [1] 319688 0
Intraoperative and post operative Hemodynamic parameters (Heart rate) will assesse by anesthesia monitors
Timepoint [1] 319688 0
At 15th, 30th, 45th, 60th, 75thand 90th minutes of the operation, at the 5th minute of extubation and intubation.
Secondary outcome [2] 319689 0
Postoperative recovery status will assesse by Aldrete Recovery Scores
Timepoint [2] 319689 0
At the 2nd and 5th minutes following extubation were recorded.

Eligibility
Key inclusion criteria
Patients aged 65 and older,
who were at least literate,
fell under the ASA I-II risk group
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had significant coronary, pulmonary, renal, hepatic diseases, neuropsychiatric diseases affecting the CNS and cognitive functions, fever and infection, metabolic and endocrinal diseases, malnutrition and dehydration, low levels of vitamin B12 and folate;those who took medications that affected CNS, who were alcohol and substance addicts, smokers, urgent cases, patients in the risk group of ASA III and above, patients younger than 65, those who scored 23 and lower in the SMMT (Standardized Mini Mental Test) performed one day before the operation were excluded from the study.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 7488 0
Turkey
State/province [1] 7488 0
Konya

Funding & Sponsors
Funding source category [1] 292606 0
University
Name [1] 292606 0
Necmettin Erbakan University Meram School of Medicine
Country [1] 292606 0
Turkey
Primary sponsor type
University
Name
Necmettin Erbakan University Meram School of Medicine
Address
Necmettin Erbakan University Meram School of Medicine,Beysehir Street Akyokus, Meram-Konya Postcode 42080
Country
Turkey
Secondary sponsor category [1] 291323 0
None
Name [1] 291323 0
Address [1] 291323 0
Country [1] 291323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294087 0
Necmettin Erbakan University Meram School of Medicine
Ethics committee address [1] 294087 0
Necmettin Erbakan University Meram School of Medicine,Beysehir Street Akyokus, Meram-Konya Postcode 42080
Ethics committee country [1] 294087 0
Turkey
Date submitted for ethics approval [1] 294087 0
01/06/2012
Approval date [1] 294087 0
27/06/2012
Ethics approval number [1] 294087 0
2012/45

Summary
Brief summary
Forty patients aged 65 and older planned for elective abdominal surgery were randomly divided into two groups. While 5 ml- physiological serum was administered to the control group, ketamine group received 0,5 mg/kg ketamine in IV form 5 minutes before induction. Hemodynamic variables,were measured every 15 min until the end of the operation. Standardized Mini Mental Test (SMMT) were performed 24 hours prior to the operation and repeated 1 hour and 6hours after the operation to evaluate the cognitive functions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62402 0
Dr Osman Sahin
Address 62402 0
Konya Training and Research Hospital, Anesthesiology and Reanimation Department, Haci Saban Mah. Meram Yeniyol Caddesi No:97 Post code: 42090 Meram KONYA
Country 62402 0
Turkey
Phone 62402 0
+90 3322212250
Fax 62402 0
Email 62402 0
[email protected]
Contact person for public queries
Name 62403 0
A/Prof Hale Borazan
Address 62403 0
Necmettin Erbakan University Meram School of Medicine, Beysehir Street , Akyokus, Meram-Konya 42080
Country 62403 0
Turkey
Phone 62403 0
+90332223000
Fax 62403 0
Email 62403 0
[email protected]
Contact person for scientific queries
Name 62404 0
A/Prof Hale Borazan
Address 62404 0
Necmettin Erbakan University Meram School of Medicine, Beysehir Street , Akyokus, Meram-Konya 42080
Country 62404 0
Turkey
Phone 62404 0
+903322230000
Fax 62404 0
Email 62404 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
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