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Comparison of the effect of oral captopril in comparison with alprazolam and oral captopril in controlling blood pressure in patients with urgent hypertension.

Protocol summary

Study aim
Comparison of the effect of oral captopril in comparison with alprazolam and oral captopril in controlling blood pressure in patients with urgent hypertension
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 94 patients. Random allocation software is used for randomization.
Settings and conduct
The present study is a double-blind randomized parallel clinical trial. This study will be performed on patients with urgent hypertension referred to the emergency department of Imam Hossein Hospital in Shahroud. After ten minutes of rest after admission to the emergency department, blood pressure will be taken. After obtaining informed consent, the patient who meets the inclusion criteria will be placed in the control and intervention group based on the random allocation in the numbered envelopes. The patient's blood pressure is then retaken and recorded. In the intervention group, captopril 50 mg, alprazolam 0.5 mg, and control group captopril 50 mg and folic acid tablets are administered orally and only once for patients. Patients will be asleep and resting in bed during the study. Patients' blood pressure in both groups is taken with a mercury sphygmomanometer at 90, 60, 30, and 120 minutes after drug administration. In this study, patients and blood pressure assessors will be unaware of the type of drug prescribed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: systolic blood pressure above 180 or diastolic above 110, age group 18-80 years, ability to understand and sign informed consent, insensitivity to captopril or alprazolam
Intervention groups
In the control group, the main drug captopril will be given 50 mg orally and vitamin B, and in the intervention group, captopril 50 mg along with alprazolam 0.5 mg will be given orally.
Main outcome variables
Systolic and diastolic blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220423054624N1
Registration date: 2022-05-25, 1401/03/04
Registration timing: registered_while_recruiting

Last update: 2022-05-25, 1401/03/04
Update count: 0
Registration date
2022-05-25, 1401/03/04
Registrant information
Name
Maryam Sahba
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
gity.shb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral captopril in comparison with alprazolam and oral captopril in controlling blood pressure in patients with urgent hypertension.
Public title
Efficacy of Alprazolam on blood pressure control
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Systolic blood pressure over 180 or Diastolic blood pressure over 110 age between 18-80 years old Ability to understand and sign the conscientious informed consent No previous Allergy to Captopril or Alprazolam
Exclusion criteria:
Left Acute Heart Failure Chronic Renal Failure Cardiovascular disease History of stroke History of myocardial infraction Taking other Benzodiazepines in the last week Taking Muscle Relaxant drugs such as Baclofen Taking anti-anxiety drugs from other group such as Buspirone or Zolpidem Pregnant and Lactating women Occurring an emergency situation which indicates prescribing other Antihypertensive drug based on the Doctor's diagnosis Patients who have more than 15 mmHg difference in blood pressure between arms .
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups of 47 using random allocation software. An envelope will be prepared according to the number of samples, the code of each treatment group will be placed in the envelope, and each patient will be assigned an envelope in which the treatment group is written.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: The use of captopril tablets with Folic acid tablets in one group and the use of captopril tablets and alprazolam tablets in another group that the patient is not aware of based on the same color, and shape, and through the use of drugs. Statistical Analyzer: The treatment groups will be provided to the statistical analyzer using the code for analysis.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Room 409, third floor , medical school , Shahroud University of Medical sciences and Health Services, Hafte-Tir Square ,Tehran avenue , Shahroud, Semnan, Iran
City
Shahroud
Province
Semnan
Postal code
3614773943
Approval date
2022-04-17, 1401/01/28
Ethics committee reference number
IR.SHMU.REC.1401.022

Health conditions studied

1

Description of health condition studied
Essential (primary) hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Systolic and diastolic blood pressure
Timepoint
checking blood pressure at the beginning of the study and then at 30 ,60 , 90 and 120 minutes after the intervention.
Method of measurement
using a clinical mercury manometer device for monitoring the blood pressure in a standardized manner in which patient is lying down.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, patients' blood pressure will be taken and recorded before the drug is administered lying down and the standard method using a mercury sphygmomanometer. Patients are then given a 50 mg captopril tablet and a 0.5 mg alprazolam tablet orally. The drug is prescribed only once at the beginning of the study. The patient will be lying on the bed during the study. In order to check the blood pressure of patients, at 30, 60, 90 and 120 minutes after drug administration (4 times in total), patients' blood pressure is taken and recorded with a mercury sphygmomanometer. Due to the fact that the occurrence of drug side effects is one of the consequences, at 30, 60, 90 and 120 minutes after drug administration, the patient is monitored and the occurrence of side effects is evaluated.
Category
Treatment - Drugs

2

Description
Control group: In the control group, patients' blood pressure will be taken and recorded before the drug is prescribed and the standard method will be taken using a mercury sphygmomanometer. Patients are then given a 50 mg captopril tablet with one folic acid tablet orally. The drug is prescribed only once at the beginning of the study. The patient will be lying on the bed during the study. In order to evaluate the blood pressure status of patients in the control group, in 30, 60, 90 and 120 minutes after drug administration (4 times in total), patients' blood pressure is taken and recorded with a mercury sphygmomanometer. Also, at 30, 60, 90 and 120 minutes after drug administration, the patient is monitored and the occurrence of complications is evaluated.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Dr. Mohammad Reza Khorsand Kemachali
Street address
Emergency department, Imam Hossein Hospital, Imam Hossein Square , Shahroud , Iran
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
a.noyani@shmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammad Hassan Emamian
Street address
Research Deputy, second floor, Medical school, University of Medical Science , Hafte-Tir square , Tehran avenue, Shahroud, Semnan, Iran
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5009
Email
a.noyani@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
DR. Mohammadreza khorsand Kemachali
Position
Supervisor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Room 409, Third floor , Medical School, Shahroud University of Medical Science and Health Services, Hafte Tir Square, Shahroud ,Iran
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
dr_khorsandmd@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Khorsand Kemachali
Position
Supervisor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Room 409, Third floor , Medical School, Shahroud University of Medical Science and Health Services, Hafte Tir Square, Shahroud ,Iran
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
dr_khorsandmd@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mostafa Enayatrad
Position
Statistical advisor
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Room 409, Third floor , Medical School, Shahroud University of Medical Science and Health Services, Hafte Tir Square, Shahroud ,Iran
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
Mostafaenayatrad@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
All collected data will be shared after being unidentified and analysed
When the data will become available and for how long
By the end of 2023
To whom data/document is available
For all scholars
Under which criteria data/document could be used
For use in studies
From where data/document is obtainable
Emergency department of Imam Hossein Hospital in Shahroud. Responsible person is Dr. Mohammad Reza Khorsand. Postal Code 3614773943 Contact number 09126733459 Imam Hassan Hospital in Shahroud. Emergency department
What processes are involved for a request to access data/document
dr.mohhamadreza khorsand Email dr_khorsandmd@yahoo.com
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