Comparison of the effect of oral administration of alprazolam and zolpidem on patient,s anxiety before surgery and hemodynamic variables before induction of anesthesia
Comparison of the effect of oral administration of alprazolam and zolpidem on patient,s anxiety before surgery and hemodynamic variables before induction of anesthesia
Design
For the first group, oral alprazolam (0.5 mg) and for the second group, oral zolpidem (5 mg) administered the night before surgery.
Settings and conduct
This study is performed on patients who have been admitted to the gynecology ward of Shahid Sadoughi Hospital in Yazd for abdominal surgery. Medications are given to the patient the night before the operation and anxiety and hemodynamic variables are evaluated in the morning of the operation. This study is double-blind and neither the researcher nor the patient knows the type of drug prescribed, so that the drugs are coded in two similar packages and the third person gives the drug to the patient based on the specified code.
Participants/Inclusion and exclusion criteria
Inclusion criteria: including all female patients undergoing abdominal surgery for women referred to Shahid Sadoughi Hospital in Yazd
Exclusion criteria:Existence of moderate or severe systemic disease
History of taking sedatives and sedatives
Addiction to opioids, sedatives or psychotropic drugs
Patient dissatisfaction to participate in the study
Intervention groups
(35 samples with oral administration of alprazolam and 35 samples with oral administration of zolpidem.
Main outcome variables
Their anxiety score based on VAS (0-10) and hemodynamic variables
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002963N31
Registration date:2021-05-02, 1400/02/12
Registration timing:registered_while_recruiting
Last update:2021-05-02, 1400/02/12
Update count:0
Registration date
2021-05-02, 1400/02/12
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral administration of alprazolam and zolpidem on patient,s anxiety before surgery and hemodynamic variables before induction of anesthesia
Public title
Comparison of the effect of two tranquilizer oral drugs alprazolam and zolpidem on patient,s anxiety before surgery andblood pressure and heart rate before induction of general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Includes all female patients undergoing abdominal surgery for women referred to Shahid Sadoughi Hospital in Yazd
Exclusion criteria:
Existence of moderate to severe systemic disease
history of using of sedative or tranquilizer drugs
history of addiction to opioids or any sedative or psychotropic drugs
patient disagreement for cooperation in this study
Age
From 20 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly allocate 70 eligible applicants, we randomly divide them into two groups of 35 people. For this purpose, we use Random allocation software version 1.0 under Windows to create a sequence, and by using this software we make A list which is specified from 1 to 70 with group A or B treatment
By Using this list, we give the first person who is eligible to enter the study, number one and the last person the number 70, then based on the random allocation list and by the software, it is determined which group A or B each person is in.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers themselves are unaware of which medication the patient has received, in this way, each drug is placed in a package and the packages are coded and based on the table of random numbers and specified code, the drug is given to patients by a third party who is not involved in evaluating patients and recording results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ali Ibn Abi Talib Medical School (AS), Islamic Azad University, Yazd Branch
Street address
Safaieh, Boulevard of the Shohadaie Gomnam
City
YAZD
Province
Yazd
Postal code
۸۹۱۵۸۱۳۱۳۵
Approval date
2021-03-15, 1399/12/25
Ethics committee reference number
IR.IAU.YAZD.REC.1399.067
Health conditions studied
1
Description of health condition studied
The effect of drug type on anxiety before induction of anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score
Timepoint
Before administration of study drug and before induction of anesthesia
Method of measurement
VAS(0-10)
2
Description
Systolic blood pressure
Timepoint
Before administration of study drug and before induction of anesthesia
Method of measurement
Using monitoring device
3
Description
Diastolic blood pressure
Timepoint
Before administration of study drug and before induction of anesthesia
Method of measurement
Using monitoring device
4
Description
Mean arterial pressure
Timepoint
Before administration of study drug and before induction of anesthesia
Method of measurement
Using monitoring device
5
Description
Heart Rate
Timepoint
Before administration of study drug and before induction of anesthesia
Method of measurement
Using monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the first group are given oral alprazolam (0.5 mg) the night before surgery.
Category
Treatment - Drugs
2
Description
Patients in the second group are given oral zolpidem (5 mg) the night before surgery.
Dr Seyed Mohammadreza Mortazavizadeh(Vice Chancellor for Research)
Street address
Boulevard of the Shohadaie Gomnam, Safaieh
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3187 2200
Fax
+98 35 3821 5034
Email
info@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad Islamic University Of Yazd
Proportion provided by this source
100
Public or private sector
Private
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
Yazd University of Medical Sciences
Full name of responsible person
Dr.Shokofe Behdad
Position
Faculty member and full professor of Shahid Sadoughi University of Medical Sciences, Yazd
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yazd, Bahonar Square, the central building of Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 1386
Fax
+98 35 3822 4100
Email
drbehdad@ssu.ac.ir
Web page address
http://web.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Shokofe Behdad
Position
Faculty member and full professor of Shahid Sadoughi University of Medical Sciences, Yazd
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yazd, Bahonar Square, the central building of Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 1386
Fax
+98 35 3822 4100
Email
drbehdad@ssu.ac.ir
Web page address
http://web.ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Aref
Position
Professional doctoral medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Warriors Town - Asalat Street - 10th Alley
City
Yazd
Province
Yazd
Postal code
8915117117
Phone
+98 35 3821 0176
Email
fatemeharef7504@gmail.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data obtained from the questionnaires are entered in the statistical software of SPSS version 21 and are statistically analyzed by the relevant statistical tests. The obtained statistical results and its comparison with the results of similar studies are published as a scientific article in one of the prestigious scientific journals.
When the data will become available and for how long
Access period starts from 1400
To whom data/document is available
The statistical results obtained from the statistical analysis of the data of this study will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Only the results of statistical analysis of the data of this study will be available to university researchers
From where data/document is obtainable
Dr. Shekoufeh Behdad Professor of Anesthesiology, Shahid Sadoughi University of Medical Sciences, Yazd. Mobile phone number: 09131514144 Email: behdad90@gmail.com
What processes are involved for a request to access data/document
The applicant should send his / her application by e-mail or mobile phone and the requested documents will be sent to him / her within a few days.