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Protocol summary
Based on the inclusion criteria, patients will divide into 3 control and intervention groups (1 and 2) by simple random allocation method. Interventions in groups are single-blind, premed drug is given by the researcher to the patient and the person assessing the depth of anesthesia will be unaware of the type of intervention.
Based on the inclusion criteria, patients will divide into 3 control and intervention groups (1 and 2) by simple random allocation method. The interventions in the groups are double-blind, that is, the pre-medication is given to the patient by the researcher, and the person assessing the depth of anesthesia and the statistical analyst will be unaware of the type of interventions.
Based on the inclusion criteria, patients will divide into 3 control and intervention groups (1 and 2) by simple random allocation method. InterventionsThe interventions in the groups are singledouble-blind, premed drugthat is, the pre-medication is given to the patient by the researcher to the patient, and the person assessing the depth of anesthesia and the statistical analyst will be unaware of the type of interventioninterventions.
بر اساس معیارهای ورود انتخاب و به روش تخصیص تصادفی ساده در 3 گروه کنترل و مداخله(1 و2) قرار می گیرند. بدین ترتیب که با قرار گرفتن نمونه ها در گروههای سه نفره، نفر اول از داخل کیسه که حاوی گوی های A,B,C خواهد بود. ی مداخلات در گروه ها بصورت یکسو کور می باشد، یعنی پیش دارو توسط پژوهشگر به بیمار داده می شود و فرد ارزیابی کننده عمق بیهوشی، از نوع مداخلات بی اطلاع خواهد بود
بر اساس معیارهای ورود انتخاب و به روش تخصیص تصادفی ساده در 3 گروه کنترل و مداخله(1 و2) قرار می گیرند. بدین ترتیب که با قرار گرفتن نمونه ها در گروههای سه نفره، نفر اول از داخل کیسه که حاوی گوی های A,B,C خواهد بود. مداخلات در گروه ها بصورت دوسو کور می باشد، یعنی پیش دارو توسط پژوهشگر به بیمار داده می شود و فرد ارزیابی کننده عمق بیهوشی و تحلیل گر آماری، از نوع مداخلات بی اطلاع خواهند بود
بر اساس معیارهای ورود انتخاب و به روش تخصیص تصادفی ساده در 3 گروه کنترل و مداخله(1 و2) قرار می گیرند. بدین ترتیب که با قرار گرفتن نمونه ها در گروههای سه نفره، نفر اول از داخل کیسه که حاوی گوی های A,B,C خواهد بود. ی مداخلات در گروه ها بصورت یکسودوسو کور می باشد، یعنی پیش دارو توسط پژوهشگر به بیمار داده می شود و فرد ارزیابی کننده عمق بیهوشی و تحلیل گر آماری، از نوع مداخلات بی اطلاع خواهدخواهند بود
Patients choice in class I anesthesia, age group 20-50 years with no serious disease.
Patients choice in class I anesthesia, age group 15-60 years with no serious disease.
Patients choice in class I anesthesia, age group 2015-5060 years with no serious disease.
بیمارانی که کلاس I بیهوشی و گروه سنی 50-20 سال که فاقد بیماری زمینه ای باشند، انتخاب خواهند شد. .
بیمارانی که کلاس I بیهوشی و گروه سنی 60-15 سال که فاقد بیماری زمینه ای باشند، انتخاب خواهند شد. .
بیمارانی که کلاس I بیهوشی و گروه سنی 5060-2015 سال که فاقد بیماری زمینه ای باشند، انتخاب خواهند شد. .
General information
20
15
2015
50
60
5060
Not randomized
Randomized
nrandrand
Single blinded
Double blinded
singldoubl
1
1
2020-05-03, 1399/02/14
2022-11-05, 1401/08/14
20202022-11-05-03 00:00:00
empty
To facilating study process, because the use of regional anesthesia methods in lower extermity surgeries, the number of patients for sampling was very limited. The spread of the Covid-19 disease has caused the suspension of sampling and intervention for almost two years.
The update was done after consulting with legal supervisors and using the experiences of anesthesiologists without affecting the scientific quality of the study.
To facilating study process, because the use of regional anesthesia methods in lower extermity surgeries, the number of patients for sampling was very limited. The spread of the Covid-19 disease has caused the suspension of sampling and intervention for almost two years. The update was done after consulting with legal supervisors and using the experiences of anesthesiologists without affecting the scientific quality of the study.
empty
برای تسهیل فرآیند مطالعه، زیرا بدلیل استفاده از روشهای بیحسی منطقهای در جراحیهای اندام تحتانی، تعداد بیماران برای نمونهگیری بسیار محدود بود. شیوع بیماری کووید 19 باعث تعلیق نمونه برداری و مداخله به مدت نزدیک به دو سال شده است.
این به روز رسانی پس از مشاوره با ناظران قانونی و استفاده از تجربیات متخصصین بیهوشی بدون تأثیر بر کیفیت علمی مطالعه انجام شد.
برای تسهیل فرآیند مطالعه، زیرا بدلیل استفاده از روشهای بیحسی منطقهای در جراحیهای اندام تحتانی، تعداد بیماران برای نمونهگیری بسیار محدود بود. شیوع بیماری کووید 19 باعث تعلیق نمونه برداری و مداخله به مدت نزدیک به دو سال شده است. این به روز رسانی پس از مشاوره با ناظران قانونی و استفاده از تجربیات متخصصین بیهوشی بدون تأثیر بر کیفیت علمی مطالعه انجام شد.
Class I Anesthesia,
Age group 20-50 years
Not have serious illnesses and problems affecting body function and thermodynamics such as diabetes and cardiovascular disease
Class I and II Anesthesia,
Age group 15-60 years
Not have serious illnesses and problems affecting body function and thermodynamics such as diabetes and cardiovascular disease
Class I and II Anesthesia, Age group 2015-5060 years Not have serious illnesses and problems affecting body function and thermodynamics such as diabetes and cardiovascular disease
کلاس I بیهوشی
گروه سنی 50-20 سال
دارای بیماری و مشکلات جدی موثر بر عمکرد و همودینامیک بدن نظیر دیابت و بیماری های قلبی عروقی نباشند
کلاس I و II بیهوشی
گروه سنی 60-15 سال
دارای بیماری و مشکلات جدی موثر بر عمکرد و همودینامیک بدن نظیر دیابت و بیماری های قلبی عروقی نباشند
کلاس I و II بیهوشی گروه سنی 5060-2015 سال دارای بیماری و مشکلات جدی موثر بر عمکرد و همودینامیک بدن نظیر دیابت و بیماری های قلبی عروقی نباشند
Using random number tables (random blocks A, B, C), patients are placed in one of intervention groups 1 (alprazolam), intervention group 2 (lavender scent) and group 3 (control group)
Using random number tables (random blocks A, B, C), patients are placed in one of intervention groups 1 (alprazolam), intervention group 2 (lavender scent) and group 3 (control group)
بیماران با استفاده از جدول اعداد تصادفی(بلوک های تصادفی A,B,C) در یک از گروه های مداخله 1(آلپرازولام)، گروه مداخله 2(رایحه اسطوخدوس) و گروه 3(گروه کنترل) قرار می گیرند
بیماران با استفاده از جدول اعداد تصادفی(بلوک های تصادفی A,B,C) در یک از گروه های مداخله 1(آلپرازولام)، گروه مداخله 2(رایحه اسطوخدوس) و گروه 3(گروه کنترل) قرار می گیرند
Premeditation therapy with alprazolam for group 1 and aromatherapy for group 2, will be performed by the researcher in the morning of surgery day. while the person who asses the depth of anesthesia, will not be aware of groups and kind of Premed.
Premeditation therapy with alprazolam for group 1 and aromatherapy for group 2, will be performed by the researcher in the morning of surgery day. The person who evaluating the depth of anesthesia and the statistical analyst does not know the type of pre-medication received by the patient or whether he is in the intervention or control group
Premeditation therapy with alprazolam for group 1 and aromatherapy for group 2, will be performed by the researcher in the morning of surgery day. while theThe person who assesevaluating the depth of anesthesia, will and the statistical analyst does not be awareknow the type of groups and kind of Premed.pre-medication received by the patient or whether he is in the intervention or control group
تجویز پیش دارو(پریمد) شامل آلپرازولام برای گروه 1 و رایحه درمانی برای گروه 2 در صبح روز عمل جراحی، توسط پژوهشگر انجام می شود در حالی که فرد ارزیابی کننده عمق بیهوشی از نوع پیش داروی دریافتی بیمار یا قرار گرفتن وی در گروه کنترل 3 آگاهی ندارد
تجویز پیش دارو(پریمد) شامل آلپرازولام برای گروه 1 و رایحه درمانی برای گروه 2 در صبح روز عمل جراحی، توسط پژوهشگر انجام می شود فرد ارزیابی کننده عمق بیهوشی و تحلیل گر آماری از نوع پیش داروی دریافتی بیمار یا قرار گرفتن وی در گروه مداخله یا کنترل آگاهی ندارد
تجویز پیش دارو(پریمد) شامل آلپرازولام برای گروه 1 و رایحه درمانی برای گروه 2 در صبح روز عمل جراحی، توسط پژوهشگر انجام می شود در حالی که فرد ارزیابی کننده عمق بیهوشی و تحلیل گر آماری از نوع پیش داروی دریافتی بیمار یا قرار گرفتن وی در گروه مداخله یا کنترل 3 آگاهی ندارد
Health conditions studied
#1
empty
S62.91XA
S62.91XA
empty
Unspecified fracture of right wrist and hand
Unspecified fracture of right wrist and hand
empty
Fracture of the bones of the right hand
Fracture of the bones of the right hand
empty
شکستگی استخوان های دست راست
شکستگی استخوان های دست راست
#2
empty
S62.92XA
S62.92XA
empty
Unspecified fracture of right wrist and hand
Unspecified fracture of right wrist and hand
empty
Fracture of the bones of the left hand
Fracture of the bones of the left hand
empty
شکستگی استخوان های دست چپ
شکستگی استخوان های دست چپ
#3
empty
S39.91XA
S39.91XA
empty
Abdominal surgeries
Abdominal surgeries
empty
Abdominal and gastrointestinal surgeries
Abdominal and gastrointestinal surgeries
empty
جراحی های ناحیه شکم و دستگاه گوارش
جراحی های ناحیه شکم و دستگاه گوارش
Recruitment centers
#1
Name of recruitment center - English: All of the study samples will be selected from patients admitted to orthopedic surgery due to bone f
Name of recruitment center - Persian: کلیه نمونه های پژوهش از بیمارانی که در بیمارستان کوثر سمنان بستری بوده و بدلیل شکستگی استخوان کاندید
Full name of responsible person - English: سیف الله علائی
Full name of responsible person - Persian: sefollah Alaei
Street address - English: Amin
Street address - Persian: امین
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3514993437
Phone: +98 23 3344 1022
Fax: +98 23 3344 1021
Email: alaei@semums.ac.ir
Web page address: https://semums.ac.ir/
Name of recruitment center - English: Kosar Hospital
Name of recruitment center - Persian: بیمارستان کوثر سمنان
Full name of responsible person - English: Sefollah Alaei
Full name of responsible person - Persian: سیف الله علائی
Street address - English: Amin
Street address - Persian: امین
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3514993437
Phone: +98 23 3344 1022
Fax: +98 23 3344 1021
Email: alaei@semums.ac.ir
Web page address: https://semums.ac.ir/
Name of recruitment center - English: All of the study samples will be selected from patients admitted to orthopedic surgery due to bone fKosar Hospital Name of recruitment center - Persian: کلیه نمونه های پژوهش از بیمارانی که در بیمارستان کوثر سمنان بستری بوده و بدلیل شکستگی استخوان کاندید Full name of responsible person - English: سیف الله علائیSefollah Alaei Full name of responsible person - Persian: sefollah Alaeiسیف الله علائی Street address - English: Amin Street address - Persian: امین City - English: Semnan City - Persian: سمنان Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3514993437 Phone: +98 23 3344 1022 Fax: +98 23 3344 1021 Email: alaei@semums.ac.ir Web page address: https://semums.ac.ir/
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: محمد رضا عسگری
Full name of responsible person - Persian: Mohammad Reza Asgari
Street address - English: Damghan Road, Semnan University of Medical Sciences
Street address - Persian: جاده دامغان، مجتمع آموزشی دانشگاه علوم پزشکی سمنان
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3514993437
Phone: +98 23 3365 4190
Fax: +98 23 3365 4190
Email: rds@semums.ac.ir
Web page address: https://semums.ac.ir/
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Reza Asgari
Full name of responsible person - Persian: محمد رضا عسگری
Street address - English: Damghan Road, Semnan University of Medical Sciences
Street address - Persian: جاده دامغان، مجتمع آموزشی دانشگاه علوم پزشکی سمنان
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3514993437
Phone: +98 23 3365 4190
Fax: +98 23 3365 4190
Email: rds@semums.ac.ir
Web page address: https://semums.ac.ir/
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: محمد رضا عسگریMohammad Reza Asgari Full name of responsible person - Persian: Mohammad Reza Asgariمحمد رضا عسگری Street address - English: Damghan Road, Semnan University of Medical Sciences Street address - Persian: جاده دامغان، مجتمع آموزشی دانشگاه علوم پزشکی سمنان City - English: Semnan City - Persian: سمنان Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3514993437 Phone: +98 23 3365 4190 Fax: +98 23 3365 4190 Email: rds@semums.ac.ir Web page address: https://semums.ac.ir/
Protocol summary
Study aim
Compare the effect of Lavender essential oil and Alprazolam on deep of anesthesia and thermodynamic parameters during general anesthesia process
Design
Based on the inclusion criteria, patients will divide into 3 control and intervention groups (1 and 2) by simple random allocation method. The interventions in the groups are double-blind, that is, the pre-medication is given to the patient by the researcher, and the person assessing the depth of anesthesia and the statistical analyst will be unaware of the type of interventions.
Settings and conduct
The study will be performed in the hospital setting, between the hours of 7–8 am (2–3 hours before surgery) for group 1, 0.5 mg oral alprazolam, and for group 2, Three drops of lavender on a clean cloth or dressing is inhaled inhaled for 15-20 minutes by patients and. Routine medications administered to the patient include midazolam 0.02 mg / kg, fentanyl 2 ug / kg, or sufenta 0.2 ug / kg for anesthesia initiation.
Participants/Inclusion and exclusion criteria
Patients choice in class I anesthesia, age group 15-60 years with no serious disease.
Intervention groups
In intervention group 1 (alprazolam), in intervention group 2 (lavender aromatherapy) and in the non-intervention control group, only vital signs and depth of anesthesia are evaluated.
Main outcome variables
In this study, vital signs such as heart rate, blood pressure (systolic, diastolic, and mean arterial pressure MAP), respiratory rate and SPO2 level will be assessed before administration of pre-medication, before anesthetic, and concurrent with anesthesia(per operative) and 5 minutes after surgery. Depth of anesthesia during surgery for 3 times (starting time of surgery, mid-surgery and finishing the last part of surgery) and also after surgery.
General information
Reason for update
To facilating study process, because the use of regional anesthesia methods in lower extermity surgeries, the number of patients for sampling was very limited. The spread of the Covid-19 disease has caused the suspension of sampling and intervention for almost two years.
The update was done after consulting with legal supervisors and using the experiences of anesthesiologists without affecting the scientific quality of the study.
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045659N1
Registration date:2019-12-28, 1398/10/07
Registration timing:prospective
Last update:2022-08-12, 1401/05/21
Update count:1
Registration date
2019-12-28, 1398/10/07
Registrant information
Name
Sefollah Alaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
alaei@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-04, 1398/10/14
Expected recruitment end date
2022-11-05, 1401/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effectiveness of Lavender essential oil and Alprazolam on anesthesia and hemodynamic parameters during general anesthesia process
Public title
effect of Lavender essential oil and Alprazolam on anesthesia and hemodynamic parameters during general anesthesia process
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Class I and II Anesthesia,
Age group 15-60 years
Not have serious illnesses and problems affecting body function and thermodynamics such as diabetes and cardiovascular disease
Exclusion criteria:
History of mental illness or brain injury,
current use of sedatives, opiates, psychotropics drugs, patients who do not cooperate,
history of allergies or olfactory problems,
pre- and inoperative body temperature rise,
use of medications effective on sleep (such as phenobarbital)
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Using random number tables (random blocks A, B, C), patients are placed in one of intervention groups 1 (alprazolam), intervention group 2 (lavender scent) and group 3 (control group)
Blinding (investigator's opinion)
Double blinded
Blinding description
Premeditation therapy with alprazolam for group 1 and aromatherapy for group 2, will be performed by the researcher in the morning of surgery day. The person who evaluating the depth of anesthesia and the statistical analyst does not know the type of pre-medication received by the patient or whether he is in the intervention or control group
Placebo
Not used
Assignment
Parallel
Other design features
The current study aims to help expand the use of non-pharmacological methods in the anesthesia and surgery process.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences Ethics Committee
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Approval date
2019-11-18, 1398/08/27
Ethics committee reference number
IR.SEMUMS.REC.1398.202
Health conditions studied
1
Description of health condition studied
Fractures of various organs that are surgically repaired under anesthesia
ICD-10 code
S72.04
ICD-10 code description
Fracture of base of neck of femur
2
Description of health condition studied
Femoral neck fracture
ICD-10 code
S72.043
ICD-10 code description
Displaced fracture of base of neck of unspecified femur
3
Description of health condition studied
Fracture of the bones of the right hand
ICD-10 code
S62.91XA
ICD-10 code description
Unspecified fracture of right wrist and hand
4
Description of health condition studied
Fracture of the bones of the left hand
ICD-10 code
S62.92XA
ICD-10 code description
Unspecified fracture of right wrist and hand
5
Description of health condition studied
Abdominal and gastrointestinal surgeries
ICD-10 code
S39.91XA
ICD-10 code description
Abdominal surgeries
Primary outcomes
1
Description
The depth of anesthesia is evaluated peroperation and immediately after surgery.
Timepoint
Depth of anesthesia during surgery for 3 times will be assessed. The assessment time is in starting of surgery, mid-surgery and finishing the last part of surgery and also after surgery, 5 minutes after being placed on the recovery bed .
Method of measurement
Depth of anesthesia is measured by the Bispectral index (BIS) device. The patient's blood pressure is also measured using a digital blood pressure monitor
Secondary outcomes
1
Description
Vital sign include the patient's breathing, pulse rate and blood pressure measured by the assessor as well as with the help of a digital Sphygmomanometer.
Timepoint
Vital signs will be measured before prescription medication, 5 minutes after surgery, before anesthesia, at the time of surgery, mid-surgery, and after the last part of the surgical intervention. . It will be also measured 5 minutes after surgery on the recovery bed.
Method of measurement
By the assessor as well as with the help of a digital Sphygmomanometer
Intervention groups
1
Description
2-3 hours before surgery premed will be administrated. For group 1, the dose of oral alprazolam is 0.5 mg.
Category
Treatment - Drugs
2
Description
Intervention group: 3 drops of lavender that is poured on a clean cloth or gauze and inhaled for 15-20 minutes.
Category
Treatment - Drugs
3
Description
Control group: As a control group, they receive only routine medications
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Sefollah Alaei
Street address
Amin
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3344 1022
Fax
+98 23 3344 1021
Email
alaei@semums.ac.ir
Web page address
https://semums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asgari
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3365 4190
Fax
+98 23 3365 4190
Email
rds@semums.ac.ir
Web page address
https://semums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sefollah Alaei
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3365 4190
Fax
+98 23 3365 4191
Email
alaei@semums.ac.ir
Web page address
https://semums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Abdullah Pour
Position
Anesthesiologist and Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amin
City
Semnan
Province
Semnan
Postal code
3519735763
Phone
009831420
Email
ّFelordce@yahoo.com
Web page address
https://semums.ac.ir.
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sefollah Alaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3365 4190
Fax
+98 23 3365 4191
Email
alaei@semums.ac.ir
Web page address
https://semums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Baseline data of participants' such as age, sex, and kind of disease, intervention, and outcomes could be available to others through the publication of articles
When the data will become available and for how long
It is available to everyone indefinitely by publishing the article
To whom data/document is available
research center of Semnan University of Medical Sciences and researchers in the field of anesthesiology and intensive care could access the anonymous documentation by providing appropriate reasons.
Under which criteria data/document could be used
The main finding data will be available to the public through articles. More detailed data will be made available to researchers and specialists through correspondence with the research team
From where data/document is obtainable
By contact with the Correspond author in the published articles
What processes are involved for a request to access data/document
Introduce himself and mentioning personal, professional and organizational characteristics as well as the reasons for accessing to more detailed information and how to use this information.
Comments
It seems that through the publication of the articles, the main research findings can be available to practitioners and researchers in anesthesiology and intensive care fields.