Comparison of the effect of dexmedetomidine vs midazolam infusion on the agitation level and hemodynamic changes in patients with non-traumatic ICH and IVH caused by hypertension in patients admitted to the ICU
Comparison of the effect of dexmedetomidine infusion against midazolam on the level of agitation and hemodynamic changes in patients with HICH and HIVH intubated in ICU
Design
A clinical trial with two parallel groups, double-blind, randomized, phase 4 on 68 patients who were randomly divided by Excel's rand function.
Settings and conduct
after ICU admission and intubation, the patients will be divided into two groups secretly and will receive sedative drugs with the mentioned dose. Then the data collectors record the results of the study blindly.
Participants/Inclusion and exclusion criteria
Patients suspected of ICH or IVH will be included in the study after confirming the disease and obtaining consent from the patient or his legal guardian.
The inclusion criteria are: having ICH or IVH due to high blood pressure; ICU admission; Necessity of intubation; being at least 18 years old
Exclusion criteria are: heart rate less than 60; lack of patient sedation even with the maximum dose of midazolam and dexmedetomidine; MAP less than or equal to 7
Intervention groups
The midazolam group will receive 2mg of midazolam and the patients in the dexmedetomidine group will receive 0.5mg/kg of dexmedetomidine within 10 minutes. After receiving the first dose, the anesthesiologist will determine the amount of drug infusion based on the patient's sedation conditions and Ramsay Sedation Score. The minimum and maximum infusion rates in the midazolam group will be between 1 and 2 mg/hour and in the dexmedetomidine group between 0.2 and 0.5 mg/kg/hour.
Main outcome variables
Ramsay Sedation Scale and hemodynamic factors of the patient including heart rate, spo2 and mean arterial pressure and the amount of narcotic required in the first 30 minutes after entering the ICU and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours and 24 hours. Hours after arrival
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230101057010N1
Registration date:2023-12-20, 1402/09/29
Registration timing:prospective
Last update:2023-12-20, 1402/09/29
Update count:0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
Misagh Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3442 7001
Email address
misagh.rostami1988@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of dexmedetomidine vs midazolam infusion on the agitation level and hemodynamic changes in patients with non-traumatic ICH and IVH caused by hypertension in patients admitted to the ICU
Public title
Comparison of the effect of dexmedetomidine vs midazolam infusion on the agitation level and hemodynamic changes in patients with hypertension-caused ICH and IVH
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ICH or IVH due to high blood pressure
ICU admission
Patient intubation
be at least 18 years old
Consent of the patient or legal guardian in terms of entering the study
Exclusion criteria:
A heart rate of less than 60 is excluded from the study after receiving atropine.
If the patient is not sedated with the maximum dose of midazolam and dexmedetomidine (Ramsay Sedation Scale above 4), the patient will be prescribed narcotics and will be excluded from the study.
MAP less than or equal to 7
Lack of consent of the patient or legal guardian
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
68 intubated patients suffering from non-traumatic ICH and IVH caused by hypertension who were admitted to the ICUs of Shahid Madani Hospital in Karaj in 2023 were selected for the study, and with the help of rand function of Excel software we randomly divide the individual into two groups: midazolam and dexmedetomidine (34 people each).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and their legal guardians are included in the study without knowing the type of sedative drug. Also, those responsible for data collection will be unaware of the type of medication the patient received, and the medication will only be known to the attending physician and ICU nurses.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
alborz university of medical sciences
Street address
Taleghani Blvd
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2023-10-07, 1402/07/15
Ethics committee reference number
IR.ABZUMS.REC.1402.186
Health conditions studied
1
Description of health condition studied
Nontraumatic intracranial hemorrhage
ICD-10 code
I62.9
ICD-10 code description
Nontraumatic intracranial hemorrhage, unspecified
Primary outcomes
1
Description
Agitation level
Timepoint
It will be measured and recorded at different times, including upon arrival, the first 30 minutes after entering the ICU, and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours, and 24 hours after entering the ICU.
Method of measurement
Ramsay Sedation Scale
Secondary outcomes
1
Description
vital sign
Timepoint
Upon arrival, the first 30 minutes after entering the ICU and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours and 24 hours after entering the ICU will be assessed and recorded.
The need to use narcotic drugs to maintain sedation
Timepoint
Upon arrival, the first 30 minutes after entering the ICU and then 1 hour, 2 hours, 3 hours, 6 hours, 18 hours and 24 hours after entering the ICU will be assessed and recorded.
Method of measurement
Ramsay Sedation Scale
Intervention groups
1
Description
Intervention group: Dexmedetomidine: This drug is a selective alpha-2-adrenoceptor agonist that can calm patients hospitalized in ICU and is available in 100MCG/2ML vials. Patients in this group will receive an infusion of 0.5 mg/kg of this drug over 10 minutes upon arrival in the ICU. Then the maintenance dose will be 0.2 to 0.5 mg/kg per hour based on the amount of sedation.
Category
Treatment - Drugs
2
Description
Intervention group: Midazolam: This drug is a relatively short-acting benzodiazepine drug that has anti-anxiety and sedative effects and can calm patients hospitalized in ICU, and in this study, 5mg/1ml ampoules of this drug will be used. Patients in this group will receive an infusion of 2 mg of this drug over 10 minutes upon arrival in the ICU. Then the maintenance dose will be 1 to 2 mg per hour based on the amount of sedation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Hospital Karaj
Full name of responsible person
Sevak Hatamian
Street address
Mahan Blvd
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3442 7001
Email
drsevak_hatamian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Sevak Hatamian
Street address
Taleghani Blv
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
info@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All potential data, including the data file of the participants, the informed consent form, and the study protocol will be shared after de-identifying people, according to the protocols of Alborz University of Medical Sciences.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data of this study will be available to perform analyzes related to the safety and efficacy of the investigated drugs.
From where data/document is obtainable
Dr. Sevak Hatmian
What processes are involved for a request to access data/document
The information will be accessible after being reviewed by the research vice-chancellor of Alborz University of Medical Sciences