1. Home
  2. Approved trials
  3. » فارسی

Comparison of sedation effect of midazolam and muscle haloperidol in treatment of agitation of patients

Protocol summary

Study aim
Considering that studies performed in the treatment of agitation have been performed on patients after surgery and the cause of agitation in these patients can be as a side effect of anesthesia; However, agitation in the emergency department is due to other factors such as psychological causes, alcohol poisoning, etc., and studies in this field are limited. Also considering that the use of benzodiazepines may cause complications such as delirium in patients; Therefore, the aim of this study was to compare the sedative effect of midazolam and haloperidol muscle on the treatment of agitation and its complications in patients referred to the emergency department of Khatam Al-Anbia Hospital in Zahedan in 2019-2020.
Design
Assignment to each of the two groups will be randomly assigned blocking with ten blocks. A total of 56 people in each group and a total of 112 were estimated that 60 people from each group will enter for more assurance and if conditions are available and for higher accuracy.
Settings and conduct
Samples will be made based on the admission conditions of patients available from patients referred to the emergency room of Khatam Al-Anbia Hospital (PBUH) in Zahedan.
Participants/Inclusion and exclusion criteria
Includes age 15 to 60 years, class π and ASA Ι, with a score above 28 on the agitation measurement scale.
Intervention groups
After obtaining the consent of the patient and having the desired criteria, the drugs are injected intramuscularly into the patient's left deltoid muscle with a 2 cc syringe. After injecting the drug, the patient is monitored for two hours. After 30, 60 and 15 minutes, they are measured for drug response (agitation control) and at the end of two hours for side effects.
Main outcome variables
Acute agitation, emergency department, haloperidol, midazolam, sedation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200720048146N1
Registration date: 2020-10-04, 1399/07/13
Registration timing: prospective

Last update: 2020-10-04, 1399/07/13
Update count: 0
Registration date
2020-10-04, 1399/07/13
Registrant information
Name
Mohamadhosen Ajdary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3223 6976
Email address
mohamadhosenajdary1347zabol@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sedation effect of midazolam and muscle haloperidol in treatment of agitation of patients
Public title
Comparison of sedation effect of midazolam and muscle haloperidol in treatment of agitation of patients referring to emergency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Includes age 15 to 60 years Class п ASA Ι Score above 28 on the agitation measurement scale
Exclusion criteria:
Patient dissatisfaction (or legal partner) Unstable vital signs (blood pressure less than 90 mm Hg, heart rate below 60 and above 120 beats per minute, oxygen saturation level below 90%, level of consciousness less than agitation) History of heart disease and liver and kidney failure Pregnancy and lactation The patient is very restless and has the potential to harm himself and others and can not wait for a response to intramuscular injection of the drug. Poisoning with an unknown drug A history of active seizures requires medication Myasthenia Gravis Bone marrow suppression Patients with coagulation disorders such as hemophilia in whom intramuscular injection is contraindicated Thyrotoxicosis Hypersensitivity to midazolam or haloperidol
Age
From 15 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
نمونه ها بر اساس شرایط ورود بیماران بصورت در دسترس از مراجعین به اورژانس بیمارستان خاتم الانبیاء ( ص ) زاهدان صورت خواهد گرفت و اختصاص به هر یک از دو گروه بصورت اختصاص تصادفی بلوک بندی شده با بلوک های ده تایی خواهد بود
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting patients for inclusion and exclusion criteria, drugs including midazolam 5mg or haloperidol 5mg are prepared by block randomization method. They are coded by the person in charge of the research, so that the doctor and the patient do not know the type of injectable drug.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Ethics System in Biomedical Research
Street address
Khatam Hospital Emergency
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
981777674
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.ZAUMS.REC.1399.070

Health conditions studied

1

Description of health condition studied
Agitation
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation

Primary outcomes

1

Description
Agitation
Timepoint
The patient is monitored for two hours after the injection. After 30, 60 and 15 minutes, they are measured for drug response (agitation control) and at the end of two hours for side effects.
Method of measurement
Drug response rate is defined according to the agitation measurement scale (score less than 28).

2

Description
Midazolam and haloperidol
Timepoint
At the beginning of the intervention
Method of measurement
Medications containing midazolam 5mg, or haloperidol 5mg, are prepared by block randomization. They are coded by the person in charge of the research, so that the doctor and the patient do not know the type of injectable drug. After obtaining the consent of the patient and having the desired criteria, the drugs are injected intramuscularly into the patient's left deltoid muscle with a 2 cc syringe.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Haloperidol 5mg is prepared by block randomization method. It is coded by the researcher, so that the doctor and the patient do not know the type of injectable drug. After obtaining the consent of the patient and having the desired criteria, the drugs are injected intramuscularly into the patient's left deltoid muscle with a 2 cc syringe. The patient is monitored for two hours after the injection. After 30, 60 and 15 minutes, it is measured in terms of drug response (agitation control) and at the end of two hours, in terms of side effects. Drug response rate is defined according to the agitation measurement scale (score less than 28).
Category
Treatment - Drugs

2

Description
Control group: Midazolam 5mg is prepared by block randomization method. It is coded by the researcher, so that the doctor and the patient do not know the type of injectable drug. After obtaining the consent of the patient and having the desired criteria, the drugs are injected intramuscularly into the patient's left deltoid muscle with a 2 cc syringe. The patient is monitored for two hours after the injection. After 30, 60 and 15 minutes, it is measured in terms of drug response (agitation control) and at the end of two hours, in terms of side effects. Drug response rate is defined according to the agitation measurement scale (score less than 28).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al-Anbia Hospital Emergency Room (PBUH)
Full name of responsible person
Mohammad hossein Ajdari
Street address
Khatam Hospital Emergency
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
981777674
Phone
+98 54 3251 9517
Email
mohamadhosenajdary1347zabol@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
mohammad hossein Ajdari
Street address
Khatam Hospital Emergency
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
981777674
Phone
+98 54 3251 9517
Fax
Email
mohamadhosenajdary1347zabol@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
mohammad hossein Ajdari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Khatam Hospital Emergency
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
981777674
Phone
+98 54 3251 9517
Email
mohamadhosenajdary1347zabol@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
mohammad hpssein Ajdari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Khatam Hospital Emergency
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
981777674
Phone
+98 54 3251 9517
Email
mohamadhosenajdary1347zabol@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
mohammad hossein Ajdari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Khatam Hospital Emergency
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817776747
Phone
+98 54 3251 9517
Email
mohamadhosenajdary1347zabol@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...