Comparison of the effect of oral administration of alprazolam and zaleplon on patient,s anxiety before surgery and hemodynamic variables before induction of anesthesia
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 66 patients. Random allocation software version 1.0 under Windows is used for randomization.
Settings and conduct
This study is performed on patients who have been admitted to the Kowsar 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: all female patients undergoing abdominal surgery referred to Shahid Sadoughi Hospital in Yazd. Non-inclusion criteria: Existence of moderate or severe systemic disease; History of taking sedatives and anti-anxiety drugs; Addiction to opioids, sedatives or psychotropic drugs; dissatisfaction to participate in the study
Intervention groups
Intervention group: In this group, 33 patients are randomly given 5 mg zalpon tablets orally the night before surgery. Control group: In this group, 33 patients were randomly assigned to take alprazolam 0.5 mg tablets orally the night before surgery.
Main outcome variables
Anxiety score based on VAS (0-10); Systolic blood pressure; diastolic blood pressure; mean arterial blood pressure; heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100102002963N33
Registration date:2021-10-18, 1400/07/26
Registration timing:registered_while_recruiting
Last update:2021-10-18, 1400/07/26
Update count:0
Registration date
2021-10-18, 1400/07/26
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
2021-10-12, 1400/07/20
Expected recruitment end date
2022-01-10, 1400/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of alprazolam and zaleplon on anxiety in the patients candidate for surgery
Public title
The effect of two different tranquilizer drugs on anxiety in the patients candidate for surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients
Candidate for abdominal surgery
Referred to Kowsar ward of Shahid Sadoughi Hospital in Yazd
Exclusion criteria:
Existence of moderate to severe systemic disease patient
history of using of sedative or tranquilizer drugs
history of addiction to opioids or any sedative or psychotropic drugs
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:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly allocate 66 eligible applicants, we randomly divide them into two groups of 33 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 66 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 66, then based on the random allocation list and by the software, it is determined which group A or B each person is in. 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 person who is not involved in evaluating patients and recording results.
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 person 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 Shahid Sadoughi University of Medical Sciences
Street address
Central building of Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915887857
Approval date
2021-01-06, 1399/10/17
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.245
Health conditions studied
1
Description of health condition studied
The effect of drug 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
Based on VAS(0-10)
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
Before administration of study drug and before induction of anesthesia
Method of measurement
Using monitoring device
2
Description
Diastolic blood pressure
Timepoint
Before administration of study drug and before induction of anesthesia
Method of measurement
Using monitoring device
3
Description
Mean arterial pressure
Timepoint
Before administration of study drug and before induction of anesthesia
Method of measurement
Using monitoring device
4
Description
Heart rate
Timepoint
Before administration of study drug and before induction of anesthesia
Method of measurement
Using monitoring device
Intervention groups
1
Description
Intervention group 1: Patients in this group are given oral alprazolam (0.5 mg) the night before surgery.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in this group are given oral zaleplon (5 mg) the night before surgery.