Comparing the effect of clonidine with alprazolam on preoperative anxiety and hemodynamic variables in female patients candidates for abdominal surgery
Comparison of the effect of alprazolam and clonidin on patient’s anxiety and hemodynamic variables before induction
Design
For the first group, oral alprazolam (0.5 mg) and for the second group, oral clonidin (1/2 tablet) administered the night before surgery. This clinical trial is double blind and randomised.Patients are completely randomized in the first and second intervention groups using the random numbers table. Transient Phase: Phase 2 on 60 persons
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 18-60years 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
The first intervention group:oral administration of alprazolam 0/5 mg the night before surgery(n=30)
The second intervention group:oral administration of clonidin 0/05 mg the night before surgery(n=30)
Main outcome variables
Their anxiety score based on VAS (0-10) and hemodynamic variables(diastolic ,systolic and mean arterial blood pressure, heart rate)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240511061740N1
Registration date:2025-01-13, 1403/10/24
Registration timing:registered_while_recruiting
Last update:2025-01-13, 1403/10/24
Update count:0
Registration date
2025-01-13, 1403/10/24
Registrant information
Name
Fateme Torabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 0570
Email address
fatemetorabi@irct.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of clonidine with alprazolam on preoperative anxiety and hemodynamic variables in female patients candidates for abdominal surgery
Public title
Comparison of the effect of two tranquilizer oral drugs alprazolam and clonidin on patient,s anxiety before surgery and blood pressure and heart rate before induction of general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Includes all female 18-60 years candidates for abdominal surgery 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 18 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly allocate 60 eligible applicants, we randomly divide them into two groups of 30 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 60 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 60, 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, the blank capsules with the same color and size and appearance are filled with powdered drugs , 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