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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
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
Scientific title
The effect of preoperative anxiety and mean platelet volume (MPV) on duration of induction and propofol consumption of patient's undergoing cholecystectomy.
Secondary ID [1] 294751 0
None
Universal Trial Number (UTN)
U1111-1213-1341
Trial acronym
APT (Anxiety Propofol Trial)
Linked study record
No

Health condition
Health condition(s) or problem(s) studied:
Anxiety disorder 307648 0
Cholecystectomy 307649 0
Condition category
Condition code
Anaesthesiology 306715 306715 0 0
Anaesthetics
Mental Health 308334 308334 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Days
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.
Intervention code [1] 312740 0
Diagnosis / Prognosis
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.
Control group
Active

Outcomes
Primary outcome [1] 307254 0
Preoperative anxiety as assessed by Beck Anxiety Scale
Timepoint [1] 307254 0
Preoperative anxiety will be evaluated one day before the operation time.
Primary outcome [2] 307505 0
Mean Platelet Volume as assessed by whole-blood assay
Timepoint [2] 307505 0
Whole blood assay will be evaluated one day before operation time
Secondary outcome [1] 351290 0
Propofol induction time as assessed by observation and stopwatch
Timepoint [1] 351290 0
At the induction of anesthesia

Eligibility
Key inclusion criteria
1) 18-65 years old
2) ASA I-II
3) Patient's who will be operated for elective cholecystectomy
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2018
Actual
2/11/2018
Date of last participant enrolment
Anticipated
1/12/2018
Actual
5/03/2019
Date of last data collection
Anticipated
1/12/2018
Actual
6/03/2019
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 20812 0
Turkey
State/province [1] 20812 0
Mugla

Funding & Sponsors
Funding source category [1] 299357 0
Hospital
Name [1] 299357 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 299357 0
Turkey
Primary sponsor type
Individual
Name
Ali Ihsan Uysal
Address
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country
Turkey
Secondary sponsor category [1] 298632 0
None
Name [1] 298632 0
Address [1] 298632 0
Country [1] 298632 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300263 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 300263 0
Ethics committee country [1] 300263 0
Turkey
Date submitted for ethics approval [1] 300263 0
21/03/2018
Approval date [1] 300263 0
04/04/2018
Ethics approval number [1] 300263 0
Decision number:3325

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

Contacts
Principal investigator
Name 83086 0
Dr Ali Ihsan Uysal
Address 83086 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 83086 0
Turkey
Phone 83086 0
+905067020960
Fax 83086 0
Email 83086 0
alihsanuysal@gmail.com
Contact person for public queries
Name 83087 0
Ali Ihsan Uysal
Address 83087 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 83087 0
Turkey
Phone 83087 0
+905067020960
Fax 83087 0
Email 83087 0
alihsanuysal@gmail.com
Contact person for scientific queries
Name 83088 0
Ali Ihsan Uysal
Address 83088 0
Mugla Sitki Koçman Üniversitesi Egitim Arastirma Hastanesi Marmaris Yolu M kapisi karsisi Kötekli Mahallesi 48000 MUGLA
Country 83088 0
Turkey
Phone 83088 0
+905067020960
Fax 83088 0
Email 83088 0
alihsanuysal@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication and ending 3 months following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal,
Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyse
How or where can data be obtained?
access subject to approvals by Principal Investigator (alihsanuysal@gmail.com)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13389Study protocol  alihsanuysal@gmail.com
13390Statistical analysis plan  alihsanuysal@gmail.com



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.