Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000378729
Ethics application status
Approved
Date submitted
31/03/2013
Date registered
9/04/2013
Date last updated
6/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Is Dexmedetomidine protective from postoperative cognitive dysfunction in elderly patients after prolonged surgical anesthesia?
Scientific title
Is Dexmedetomidine protective from postoperative cognitive dysfunction in elderly patients after prolonged surgical anesthesia?
Secondary ID [1] 282215 0
nil
Universal Trial Number (UTN)
U1111-1141-2493
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prolonged lower abdominal surgery 288735 0
postoperative cognitive dysfunction 288781 0
Condition category
Condition code
Anaesthesiology 289091 289091 0 0
Other anaesthesiology
Mental Health 289092 289092 0 0
Studies of normal psychology, cognitive function and behaviour
Surgery 289137 289137 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group (D) Dexmeditomedine : will receive sevoflurane inhalation,fentanyl 100 mic, Rocronium 50 mg.and Dexmeditomedine infusion (0.4 mic/kg/hour)continous infusion from the start of the surgery till skin closure.

Group (s) Sevoflorane (or the control group) will receive sevoflurane inhalation,fentany100 mic.l, Rocronium 50 mg and Saline infusion .

For both groups, Neurocognetive tests (Montreal Cognetive Assessment and Stroop color word interference tests) will be done the night before the surgery and will be repeated 24 hours postoperatively
Intervention code [1] 286831 0
Treatment: Drugs
Comparator / control treatment
Group (s) Sevoflorane (or the control group) will receive sevoflurane inhalation,fentany100 mic., Rocronium 50 mg and Saline infusion (0.4 mic/kg/hr)
continous infusion from the start of the surgery till skin closure.
Control group
Placebo

Outcomes
Primary outcome [1] 289201 0
Measure the change between preoperative and postoperative cognitive function using Montreal Cognitive Assessment and Stroop color word interference tests .
Timepoint [1] 289201 0
24 hours postoperative
Secondary outcome [1] 302024 0
nil
Timepoint [1] 302024 0
nil

Eligibility
Key inclusion criteria
60 years old or above, bothe sexes without any neuropsychatric disorder, Scheduled for prolonged (two hours or more) abdominal surgery
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with any psychological or neurological disorder,or with preexisting cognitive dysfunction.
patients with cardiac disease

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 will be randomly allocated using computer generated
numbers. Allocation will beconcealed using
opaque sealed envelopes that will be opened just prior
to induction of general anaesthesia
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization will be done using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
uncorrected Chi-Square statistic test will be used to evaluate the null hypothesis
T test, Repeated T test, correlation,Regression test
Other statistical methods may be added according to the data collected at the end of the study.
Sample size: we hypothesize that Dexmedetomidine can reduce postoperative cognitive disorder by 20%or more.the calculated sample size of 30 patients was in order to be able to reject the null hypothesis that the incidence of postoperative cognitive disorder in both groups is equal with the power of 80%and 0.05 level of significance

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4961 0
Egypt
State/province [1] 4961 0

Funding & Sponsors
Funding source category [1] 286978 0
Self funded/Unfunded
Name [1] 286978 0
Country [1] 286978 0
Egypt
Primary sponsor type
Individual
Name
ahmad ramzy
Address
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22
Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia
Country
Saudi Arabia
Secondary sponsor category [1] 285766 0
None
Name [1] 285766 0
Address [1] 285766 0
Country [1] 285766 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289027 0
institutional review board,King Faisal specialist hospital.Jeddah
Ethics committee address [1] 289027 0
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22
Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia
Ethics committee country [1] 289027 0
Saudi Arabia
Date submitted for ethics approval [1] 289027 0
07/03/2010
Approval date [1] 289027 0
18/04/2010
Ethics approval number [1] 289027 0
2010/08

Summary
Brief summary
30 patients, above 60 years old of both sex who will be scheduled for elective abdominal surgery under general anesthesiafor more than two hours will be selected to participate in this study, Patients will be randomized into 2 groups (15 patients in each group)
Group (D) Dexmeditomedine : will receive sevoflurane inhalation,fentanyl, Rocronium and Dexmeditomedine infusion (0.4 mic/kg/hour)

Group (s) Sevoflorane (or the control group) will receive sevoflurane inhalation,fentanyl, Rocronium and Saline infusion .

For both groups, Neurocognetive tests (Montreal Cognetive Assessment and Stroop color word interference tests) will be done the night before the surgery and will be repeated 24 hours postoperatively
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38866 0
Dr Ahmad Ramzy
Address 38866 0
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22 Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia
Country 38866 0
Saudi Arabia
Phone 38866 0
+966534409797
Fax 38866 0
Email 38866 0
[email protected]
Contact person for public queries
Name 38867 0
Dr Ahmad Ramzy
Address 38867 0
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22 Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia
Country 38867 0
Saudi Arabia
Phone 38867 0
+966534409797
Fax 38867 0
Email 38867 0
[email protected]
Contact person for scientific queries
Name 38868 0
Dr Ahmad Ramzy
Address 38868 0
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22 Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia
Country 38868 0
Saudi Arabia
Phone 38868 0
+966534409797
Fax 38868 0
Email 38868 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 dexmedetomidine on the incidence of postoperative cognitive dysfunction in elderly patients after prolonged abdominal surgery.2014https://dx.doi.org/10.1016/j.egja.2014.03.007
N.B. These documents automatically identified may not have been verified by the study sponsor.