Protocol summary

Study aim
Determine the effectiveness of midazolam in blood pressure control in patients presenting to the emergency department with a diagnosis of hypertensive crisis
Design
If the code in envelope A is patient with captopril and distilled water, if the code is B, it is a medication called Midazolam and a placebo of vitamin B, and if the code C is given, then Midazolam and Captopril will be prescribed.
Settings and conduct
This is a triple-blind clinical trial that will be performed on hypertensive patients referred to Emergency Hospital of Imam Hossein Shahroud Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: systolic or diastolic blood pressure above 180 on 110 mm Hg, the age group of 80-18 years, have the power to understand and sign an informed consent. Exclusion criteria: Acute left heart failure, Chronic renal failure, cardiovascular disease, History of stroke, History of myocardial infarction, Benzodiazepines consumed in the last week, Use muscle relaxants such as baclofen or anti-anxiety drugs, Other groups such as Zolpidem or Buspirone, Captopril susceptibility, Sensitivity to midazolam, Pregnant and lactating women, The occurrence of a critical condition, according to the doctor's opinion, requires the administration of a low blood pressure medication other than midazolam and captopril. Patients with a difference between the two arms are more than 15 mm Hg.
Intervention groups
This study is randomly divided into three groups of 43 people. The two main drug captopril sublingual orally (25 mg) and midazolam intravenous injection (1 mg) will take place. Two placebos will be used in this program, which includes oral pills of vitamin B instead of captopril and distilled water instead of midazolam. After obtaining informed consent, patients will be randomly divided into three groups according to the order of the envelope.
Main outcome variables
hypertension

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181010041299N1
Registration date: 2018-12-08, 1397/09/17
Registration timing: prospective

Last update: 2018-12-08, 1397/09/17
Update count: 0
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
mostafa enayatrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 3961
Email address
mostafaenayatrad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of midazolam on blood pressure control in patients attending to emergency ward with hypertension crisis
Public title
Efficacy of midazolam on blood pressure control
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Systolic or diastolic blood pressure above 180 on 110 mm Hg age group is 18-18 years old Have the power to understand and sign a conscientious informed consent
Exclusion criteria:
Chronic renal failure Cardiovascular disease History of stroke History of myocardial infarction Benzodiazepines consumed in the last week Use of muscle relaxants such as baclofen or anti-anxiety drugs Other groups such as zoolpidum or baspirone Acute left heart failure Captopril susceptibility Sensitivity to midazolam Sensitivity to midazolam Pregnant and lactating women The occurrence of a critical condition, according to the doctor's opinion, requires the administration of a blood pressure lowering medication other than midazolam and captopril Patients with a difference between the two arms are more than 15 mm Hg
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 129
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to three groups of 43 individuals using Random allocation software and from the first patient who has met criteria for the allocation of treatments based on randomization, everyone is treated with their medication.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant: The use of placebo in addition to the current drug was administered in a group of captopril tablets and placebo, distilled water, and in the second group, the drug was injected with midazolam and vitamin B tablets, and in the third group of captopril tablets and midazolam injectable drug. Outcome evaluator: The blood pressure meter will be measured before and after the intervention by the nurse present in the shift, who is unaware of how the medications are allocated to the patient. DATA ANALYSIS: No information is available on how to allocate drugs to the groups.
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. Hafte-Tir Square. Tehran Avenue. Shahroud. Ira
City
Shahroud
Province
Semnan
Postal code
3614773947
Approval date
2018-07-24, 1397/05/02
Ethics committee reference number
IR.SHMU.REC.1397.076

Health conditions studied

1

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

Primary outcomes

1

Description
Systolic or diastolic blood pressure
Timepoint
Blood pressure measurement at the beginning of the study and 10 minutes after (before the intervention). Then at 15, 30, 45 and 60 minutes after the intervention
Method of measurement
How to measure blood pressure in a standardized manner using a mercurial barometric device.

Secondary outcomes

1

Description
Sleepiness rate
Timepoint
15, 30, 45 and 60 minutes after intervention
Method of measurement
Examination by a specialist

2

Description
Shortness of breath
Timepoint
15, 30, 45 and 60 minutes after intervention
Method of measurement
Examination by a specialist

Intervention groups

1

Description
Intervention group 1: Intravenous Midazolam injection of 1 mg and placebo vitamin B tablets
Category
Treatment - Drugs

2

Description
Intervention group 2: intravenous Midazolam injection of 1 mg and Captopril 25 mg
Category
Treatment - Drugs

3

Description
Control group 1: 25 mg captopril tablets and injected placebo distilled water
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital, Shahroud, Semnan Province
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 5009
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. Shahroud University of Medical Sciences. Hafte-Tir Square. Tehran Avenue. Shahroud. Iran.
City
Shahroud
Province
Semnan
Postal code
3614773947
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. Mohammad Reza Khorsand Kemachali
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Room 409. Third floor. medical School. Shahroud University of Medical Sciences. Hafte-Tir Square. Tehran Avenue. Shahroud. Iran.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5009
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
Doctor Amir Noyani
Position
Supervisor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Room 409. Third floor. medical School. Shahroud University of Medical Sciences. Hafte-Tir Square. Tehran Avenue. Shahroud. Iran.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5009
Email
a.noyani@shmu.ac.ir

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 Sciences. Hafte-Tir Square. Tehran Avenue. Shahroud. Iran.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5009
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 analyzed
When the data will become available and for how long
By the end of 2019
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
Supervisor
What processes are involved for a request to access data/document
By email and correspondence and justification for use
Comments
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