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Trial registered on ANZCTR
Registration number
ACTRN12618001750279
Ethics application status
Approved
Date submitted
31/08/2018
Date registered
24/10/2018
Date last updated
27/09/2021
Date data sharing statement initially provided
27/09/2021
Date results information initially provided
27/09/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
The effect of preoperative anxiety and mean platelet volume (MPV) on duration of induction and propofol consumption
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Scientific title
The effect of preoperative anxiety and mean platelet volume (MPV) on duration of induction and propofol consumption of patient's undergoing cholecystectomy.
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Secondary ID [1]
294751
0
None
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Universal Trial Number (UTN)
U1111-1213-1341
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Trial acronym
APT (Anxiety Propofol Trial)
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Linked study record
No
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Health condition
Health condition(s) or problem(s) studied:
Anxiety disorder
307648
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Cholecystectomy
307649
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Condition category
Condition code
Anaesthesiology
306715
306715
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0
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Anaesthetics
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Mental Health
308334
308334
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0
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Anxiety
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
1
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Target follow-up type
Days
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Description of intervention(s) / exposure
The preoperative anxiety levels of the patients will be assessed by Beck Anxiety Inventory at one day prior to surgery. The Beck Anxiety Inventory will be administered by an anaesthesist who is blind to study. The first 40 patients with a Beck score less than 8 will be enrolled into the first group(control group) and the first 40 patients with a Beck score equal to or greater than 8 will be enrolled into the second group. Propofol and remifentanyl infusions and intravenous rocuronium bromide will be applied for induction and maintenance of anaesthesia. The time needed for entropy less than 60 will be recorded. Calculated total propofol consumption at the intraoperative 30th minute and time needed for eye opening will be recorded.
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Intervention code [1]
312740
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Diagnosis / Prognosis
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Comparator / control treatment
The first 40 patients with a Beck score less than 8 will be enrolled into the first group(control group). Propofol and remifentanyl infusions and rocuronium bromide will be applied for induction and maintenance of anaesthesia. The time needed for entropy less than 60 will be recorded. Calculated total propofol consumption at the intraoperative 30th minute and time needed for eye opening will be recorded.
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Control group
Active
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Outcomes
Primary outcome [1]
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Preoperative anxiety as assessed by Beck Anxiety Scale
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Assessment method [1]
307254
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Timepoint [1]
307254
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Preoperative anxiety will be evaluated one day before the operation time.
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Primary outcome [2]
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Mean Platelet Volume as assessed by whole-blood assay
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Assessment method [2]
307505
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Timepoint [2]
307505
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Whole blood assay will be evaluated one day before operation time
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Secondary outcome [1]
351290
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Propofol induction time as assessed by observation and stopwatch
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Assessment method [1]
351290
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Timepoint [1]
351290
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At the induction of anesthesia
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Eligibility
Key inclusion criteria
1) 18-65 years old
2) ASA I-II
3) Patient's who will be operated for elective cholecystectomy
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1)Patient's who receive treatment for pyschiatric disease.
2)Patient's who have neurologic diease.
3)Pregnant or breastfeeding patients
4)Hypertension
5)Patient's who have metabolic and hematologic diease
6)Patient's who have received chronic medical theray for 2 months before the surgery.
7)Patient's who have chronic cardiac and respiratory diease
8)Patient's with a diease that possibly have an effect on mean platelet volume.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
For statistical analysis, the Number Cruncher Statistical System (NCSS) 2007 & PASS (Power Analysis and Sample Size) 2008 Statistical Software (Utah, USA) program will be used. The descriptive data of the study will be specified with mean, standard deviation, median, frequency, rate, minimum and maximum. Mean tests will be compared using independent t -test if data distribution normal or using nonparametric Mann-Whitney U test if data distributed normally. The p value <0.05 will be considered as statistically significant.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/11/2018
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Actual
2/11/2018
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Date of last participant enrolment
Anticipated
1/12/2018
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Actual
5/03/2019
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Date of last data collection
Anticipated
1/12/2018
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Actual
6/03/2019
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Sample size
Target
80
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Accrual to date
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Final
80
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Recruitment outside Australia
Country [1]
20812
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Turkey
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State/province [1]
20812
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Mugla
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Funding & Sponsors
Funding source category [1]
299357
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Hospital
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Name [1]
299357
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Mugla Sitki Koçman University Training and Research Hospital
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Address [1]
299357
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Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Country [1]
299357
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Turkey
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Primary sponsor type
Individual
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Name
Ali Ihsan Uysal
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Address
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Country
Turkey
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Secondary sponsor category [1]
298632
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None
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Name [1]
298632
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Address [1]
298632
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Country [1]
298632
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300263
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Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
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Ethics committee address [1]
300263
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Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Ethics committee country [1]
300263
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Turkey
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Date submitted for ethics approval [1]
300263
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21/03/2018
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Approval date [1]
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04/04/2018
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Ethics approval number [1]
300263
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Decision number:3325
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Summary
Brief summary
Our primary aim is to evaluate the relationship between preoperative anxiety as assessed by Beck Anxiety Scale and mean platelet volume (MPV) as assessed by whole-blood assay. Our secondary aims are to evaluate the relationship between preoperative MPV and propofol induction time as assessed by observation and stopwatch and preoperative MPV and propofol consumption.as assessed by directly calculating the propofol volume infused by the perfusion device. One day before the operation the anxiety levels of the patients will be measured by Beck Anxiety Scale. The patients will be alllocated into two groups. The patients with axiety score lower than 8 points will be included in the first group (GRUP A, n=40).The patients with axiety score above 8 points will be included in the second group (GRUP NA, n=40). Then the propofol induction time and propofol consumption at the 30 minutes after induction of anesthesia will be measured for each patient.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Ali Ihsan Uysal
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Address
83086
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Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Country
83086
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Turkey
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Phone
83086
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+905067020960
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Fax
83086
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Email
83086
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[email protected]
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Contact person for public queries
Name
83087
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Dr Ali Ihsan Uysal
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Address
83087
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Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Country
83087
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Turkey
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Phone
83087
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+905067020960
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Fax
83087
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Email
83087
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[email protected]
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Contact person for scientific queries
Name
83088
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Dr Ali Ihsan Uysal
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Address
83088
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Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
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Country
83088
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Turkey
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Phone
83088
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+905067020960
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Fax
83088
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Email
83088
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
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When will data be available (start and end dates)?
Immediately following publication and ending 3 months following main results publication.
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Available to whom?
Only researchers who provide a methodologically sound proposal,
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Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyse
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How or where can data be obtained?
access subject to approvals by Principal Investigator (
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
13389
Study protocol
[email protected]
13390
Statistical analysis plan
[email protected]
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.
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