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Efficacy and safety of two drugs, midazolam, and dexmedetomidine, on the sedation of mechanically ventilated children

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History
# Registration date Revision Id
2 2025-04-30, 1404/02/10 338398
1 2023-02-16, 1401/11/27 256184
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  • Protocol summary

    A parallel-group, single-blind, randomized, phase 2 clinical trial on 180 patients. Randomization sequence generation using www.randomization.com Allocation concealment will be done using opaque and numbered envelopes.
    A parallel-group, single-blind, randomized, phase 1 clinical trial on 124 patients. Randomization sequence generation using www.randomization.com Allocation concealment will be done using opaque and numbered envelopes.
    کارآزمایی بالینی ، با گروه های موازی ، یک سویه کور ، تصادفی شده، فاز 2 بر روی 180 بیمار. تولید توالی تخصیص تصادفی با استفاده از سایت www.randomization.com پنهان سازی تخصیص با استفاده از پاکت سربسته کدر و شماره دار انجام خواهد شد.
    کارآزمایی بالینی ، با گروه های موازی ، یک سویه کور ، تصادفی شده، فاز 1 بر روی 124 بیمار. تولید توالی تخصیص تصادفی با استفاده از سایت www.randomization.com پنهان سازی تخصیص با استفاده از پاکت سربسته کدر و شماره دار انجام خواهد شد.
    Children aged 1 month to 18 years who are admitted to the pediatric intensive care unit of Akbar Hospital and undergo mechanical ventilation. The study is one-sided blind (person analyzing the data).
    Children aged 1 month to 18 years who are admitted to the pediatric intensive care unit of Akbar Hospital, Ghaem Hospital, and Sheikh Hospital and undergo mechanical ventilation. The study is one-sided blind (person analyzing the data).
    کودکان 1 ماهه تا 18 ساله که در بخش مراقبت های ویژه کودکان بیمارستان اکبر بستری شده باشند و تحت تهویه مکانیکی قرار گرفته شوند. مطالعه یک سو کور است (فرد انالیزکننده داده ها)
    کودکان 1 ماهه تا 18 ساله که در بخش مراقبت های ویژه کودکان بیمارستان اکبر، بیمارستان قائم و بیمارستان شیخ بستری شده باشند و تحت تهویه مکانیکی قرار گرفته شوند. مطالعه یک سو کور است (فرد انالیزکننده داده ها)
    Dexmedomidine is injected intravenously. The bolus dose of the drug will be 0.5 micrograms per kilogram and the starting dose of the infusion will be 0.25 micrograms per kilogram per hour. While evaluating every hour, if the sedation level is lower than the target level, 0.25 micrograms per kilogram per hour will be added to the drug dose at each turn, up to a maximum of 1 microgram per kilogram per hour.
    Dexmedomidine is injected intravenously. The bolus dose of the drug will be 0.5 micrograms per kilogram and the starting dose of the infusion will be 0.25 micrograms per kilogram per hour. While evaluating every 15 minutes, if the sedation level is lower than the target level, 0.25 micrograms per kilogram per hour will be added to the drug dose at each turn, up to a maximum of 1 microgram per kilogram per hour.
    داروی دکس مدتومیدین از راه وریدی تزریق میشود . دوز بولوس دارو 0.5 میکروگرم به ازای هر کیلوگرم و دوز شروع انفوزیون 0.25 میکروگرم به ازای هر کیلوگرم در ساعت خواهد بود . ضمن ارزیابی هر یک ساعت چنانچه سطح سدیشن کمتر از سطح هدف باشد در هر نوبت 0.25 میکروگرم به ازای هر کیلوگرم در ساعت به دوز دارو اضافه خواهد شد تا حداکثر1 میکروگرم به ازای کیلوگرم در ساعت .
    داروی دکس مدتومیدین از راه وریدی تزریق میشود . دوز بولوس دارو 0.5 میکروگرم به ازای هر کیلوگرم و دوز شروع انفوزیون 0.25 میکروگرم به ازای هر کیلوگرم در ساعت خواهد بود . ضمن ارزیابی هر 15 دقیقه چنانچه سطح سدیشن کمتر از سطح هدف باشد در هر نوبت 0.25 میکروگرم به ازای هر کیلوگرم در ساعت به دوز دارو اضافه خواهد شد تا حداکثر1 میکروگرم به ازای کیلوگرم در ساعت .

  • General information

    2
    1
    180
    124
    empty
    Title: Both efficacy and safety of two drugs have been evaluated. Phase: Phase 1 clinical trial. Sample size: According to the sample size formula in the proposal, a typo has been occurred during recording the proposal. Research environment: Patients admitted to the ICUd ue to the large sample size and homogeneity of patients in the three centers of Akbar, Ghaem, and Sheikh, sampling was conducted from three centers. Evaluation: To prevent bias, evaluation was performed every 15 minutes. Secondary outcome: Re-evaluation of Ramsay score in successful patients at 6 h later in follow-up.
    empty
    عنوان: هم اثربخشی و هم ایمنی دو دارو مورد ارزیابی قرار گرفته است. فاز: فاز 1 کارآزمایی بالینی. حجم نمونه: با توجه به فرمول حجم نمونه در پروپوزال، اشتباه تایپی در هنگام ثبت پروپوزال رخ داده است. محیط تحقیق: بیماران بستری در بخش آی‌سی‌یو با توجه به حجم نمونه بالا و همگن بودن بیماران در سه مرکز اکبر، قائم و شیخ، نمونه‌گیری از سه مرکز انجام شد. ارزیابی: برای جلوگیری از سوگیری، ارزیابی هر 15 دقیقه انجام شد. نتیجه ثانویه: ارزیابی مجدد نمره Ramsy در بیماران موفق در 6 ساعت بعد در پیگیری.
    The effects of two drugs, midazolam and dexmedomidine, in sedation of children
    Efficacy and safety of two drugs, midazolam and dexmedomidine, in sedation of children
    تاثیرات دو داروی میدازولام و دکس مدتومیدین در آرامبخشی کودکان
    اثربخشی و ایمنی دو داروی میدازولام و دکس مدتومیدین در آرامبخشی کودکان
    A comparative evaluation of two drugs, midazolam, and dexmedetomidine, on the sedation of mechanically ventilated children
    Efficacy and safety of two drugs, midazolam, and dexmedetomidine, on the sedation of mechanically ventilated children
    ارزیابی تاثیرات دو داروی میدازولام و دکس مدتومیدین درسدیشن کودکان تحت تهویه مکانیکی
    اثربخشی و ایمنی دو داروی میدازولام و دکس مدتومیدین درسدیشن کودکان تحت تهویه مکانیکی
    Randomization sequence generation using www.randomization.com For 160 people, it will be coded A and B, and the allocation will be concealed using a coded and numbered sealed envelope.
    Randomization sequence generation using www.randomization.com For 124 people, it will be coded A and B, and the allocation will be concealed using a coded and numbered sealed envelope.
    تولید توالی تخصیص تصادفی با استفاده از سایت www.randomization.com برای 160 نفر بصورت کد A و B صورت می گیرد و پنهان سازی تخصیص با استفاده از پاکت سربسته کدر و شماره دار انجام خواهد شد.
    تولید توالی تخصیص تصادفی با استفاده از سایت www.randomization.com برای 124 نفر بصورت کد A و B صورت می گیرد و پنهان سازی تخصیص با استفاده از پاکت سربسته کدر و شماره دار انجام خواهد شد.

  • Secondary outcomes

    #1
    empty
    Re-evaluation of Ramsay score in successful patients at 6 hour later in follow-up
    empty
    ارزیابی مجدد نمره Ramsay در بیماران موفق 6 ساعت بعد در پیگیری
    empty
    in follow-up
    empty
    در پیگیری
    empty
    Ramsay sedation scale
    empty
    مقیاس سدیشن ramsay

  • Intervention groups

    #1
    Intervention group: Dexmedomidine is injected intravenously. The bolus dose of the drug will be 0.5 micrograms per kilogram and the starting dose of the infusion will be 0.25 micrograms per kilogram per hour. While evaluating every hour, if the sedation level is lower than the target level, 0.25 micrograms per kilogram per hour will be added to the drug dose at each turn, up to a maximum of 1 microgram per kilogram per hour.
    Intervention group: Dexmedomidine is injected intravenously. The bolus dose of the drug will be 0.5 micrograms per kilogram and the starting dose of the infusion will be 0.25 micrograms per kilogram per hour. While evaluating every 15 minute, if the sedation level is lower than the target level, 0.25 micrograms per kilogram per hour will be added to the drug dose at each turn, up to a maximum of 1 microgram per kilogram per hour.
    گروه مداخله: داروی دکس مدتومیدین از راه وریدی تزریق میشود . دوز بولوس دارو 0.5 میکروگرم به ازای هر کیلوگرم و دوز شروع انفوزیون 0.25 میکروگرم به ازای هر کیلوگرم در ساعت خواهد بود . ضمن ارزیابی هر یک ساعت چنانچه سطح سدیشن کمتر از سطح هدف باشد در هر نوبت 0.25 میکروگرم به ازای هر کیلوگرم در ساعت به دوز دارو اضافه خواهد شد تا حداکثر1 میکروگرم به ازای کیلوگرم در ساعت .
    گروه مداخله: داروی دکس مدتومیدین از راه وریدی تزریق میشود . دوز بولوس دارو 0.5 میکروگرم به ازای هر کیلوگرم و دوز شروع انفوزیون 0.25 میکروگرم به ازای هر کیلوگرم در ساعت خواهد بود . ضمن ارزیابی هر 15 دقیقه چنانچه سطح سدیشن کمتر از سطح هدف باشد در هر نوبت 0.25 میکروگرم به ازای هر کیلوگرم در ساعت به دوز دارو اضافه خواهد شد تا حداکثر1 میکروگرم به ازای کیلوگرم در ساعت .
    #2
    Control group: Children from 1 month to 15 years who are under mechanical ventilation in the intensive care unit and are injected intravenously with midazolam for sedation. The bolus dose of the drug will be 0.15 mg per kilogram and the starting dose of the infusion will be 1 microgram per kilogram per minute. While evaluating every hour, if the level of sedation is lower than the target level, 1 microgram per kilogram per minute will be added to the drug dose at each turn, up to a maximum of 4 micrograms per kilogram per minute. If we do not reach the target sedation level with the maximum dose, the treatment will be considered a failure and the second sedative drug will be added
    Control group: Children from 1 month to 15 years who are under mechanical ventilation in the intensive care unit and are injected intravenously with midazolam for sedation. The bolus dose of the drug will be 0.15 mg per kilogram and the starting dose of the infusion will be 1 microgram per kilogram per minute. While evaluating every one hour, if the level of sedation is lower than the target level, 1 microgram per kilogram per minute will be added to the drug dose at each turn, up to a maximum of 4 micrograms per kilogram per minute. If we do not reach the target sedation level with the maximum dose, the treatment will be considered a failure and the second sedative drug will be added

  • Recruitment centers

    #1
    Name of recruitment center - English: Ghaem Hospital
    Name of recruitment center - Persian: بیمارستان قائم
    Full name of responsible person - English: Majid Sezavar
    Full name of responsible person - Persian: مجید سزاوار
    Street address - English: Ahmadabad Ave.
    Street address - Persian: خیابان احمدآباد
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9176699199
    Phone: +98 51 3845 3239
    Fax:
    Email: Sezavardm@mums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Sheikh Hospital
    Name of recruitment center - Persian: بیمارستان شیخ
    Full name of responsible person - English: Majid Sezavar
    Full name of responsible person - Persian: مجید سزاوار
    Street address - English: Dr. Sheikh Ave., Tohid Square
    Street address - Persian: میدان توحید، خیابان دکتر شیخ
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9139963185
    Phone: +98 51 3726 9021
    Fax:
    Email: sezavardm@mums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: دکتر مجید غیور مبرهن
    Full name of responsible person - Persian: Dr. Majid Ghayor Mobarhan
    Street address - English: Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
    Street address - Persian: خيابان دانشگاه، ساختمان قريشي، معاونت پژوهشي دانشگاه علوم پزشکي مشهد
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 1394491388
    Phone: +98 51 3841 1538
    Fax:
    Email: GhayourM@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Majid Ghayor Mobarhan
    Full name of responsible person - Persian: دکتر مجید غیور مبرهن
    Street address - English: Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
    Street address - Persian: خيابان دانشگاه، ساختمان قريشي، معاونت پژوهشي دانشگاه علوم پزشکي مشهد
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 1394491388
    Phone: +98 51 3841 1538
    Fax:
    Email: GhayourM@mums.ac.ir
    Web page address:

Protocol summary

Study aim
Comparison of two drugs, midazolam, and dexmedetomidine, in the sedation of children under mechanical ventilation
Design
A parallel-group, single-blind, randomized, phase 1 clinical trial on 124 patients. Randomization sequence generation using www.randomization.com Allocation concealment will be done using opaque and numbered envelopes.
Settings and conduct
Children aged 1 month to 18 years who are admitted to the pediatric intensive care unit of Akbar Hospital, Ghaem Hospital, and Sheikh Hospital and undergo mechanical ventilation. The study is one-sided blind (person analyzing the data).
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Mechanically ventilated children aged 1 month to 18 years who were admitted to the intensive care unit of Akbar Hospital will be included in the study. Criteria for not entering the study: Suffering from dysfunction of the central nervous system, whether genetic or acquired
Intervention groups
Dexmedomidine is injected intravenously. The bolus dose of the drug will be 0.5 micrograms per kilogram and the starting dose of the infusion will be 0.25 micrograms per kilogram per hour. While evaluating every 15 minutes, if the sedation level is lower than the target level, 0.25 micrograms per kilogram per hour will be added to the drug dose at each turn, up to a maximum of 1 microgram per kilogram per hour.
Main outcome variables
The rate of treatment failure and the need for a second sedative drug

General information

Reason for update
Title: Both efficacy and safety of two drugs have been evaluated. Phase: Phase 1 clinical trial. Sample size: According to the sample size formula in the proposal, a typo has been occurred during recording the proposal. Research environment: Patients admitted to the ICUd ue to the large sample size and homogeneity of patients in the three centers of Akbar, Ghaem, and Sheikh, sampling was conducted from three centers. Evaluation: To prevent bias, evaluation was performed every 15 minutes. Secondary outcome: Re-evaluation of Ramsay score in successful patients at 6 h later in follow-up.
Acronym
IRCT registration information
IRCT registration number: IRCT20190522043672N3
Registration date: 2023-02-16, 1401/11/27
Registration timing: registered_while_recruiting

Last update: 2025-05-03, 1404/02/13
Update count: 1
Registration date
2023-02-16, 1401/11/27
Registrant information
Name
Majid Sezavar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3870 9225
Email address
sezavardm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of two drugs, midazolam, and dexmedetomidine, on the sedation of mechanically ventilated children
Public title
Efficacy and safety of two drugs, midazolam and dexmedomidine, in sedation of children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from dysfunction of the central nervous system, whether genetic or acquired
Exclusion criteria:
Having bradycardia Resistant hypotension during treatment
Age
From 1 month old to 18 years old
Gender
Both
Phase
1
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 124
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization sequence generation using www.randomization.com For 124 people, it will be coded A and B, and the allocation will be concealed using a coded and numbered sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The plan's statistical consultant who analyzes the data does not have information about the type of drug.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.537

Health conditions studied

1

Description of health condition studied
Other side effects of anesthesia and sedation
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia

Primary outcomes

1

Description
The rate of treatment failure and the need for a second sedative drug
Timepoint
The first day, the second day and the third day of the intervention
Method of measurement
Using the Ramsay score table

Secondary outcomes

1

Description
Duration of reaching target sedation
Timepoint
The first, second and third day of the intervention
Method of measurement
Measuring time with a timer

2

Description
Duration of mechanical ventilation
Timepoint
The day of the patient's discharge
Method of measurement
patient file

3

Description
Bradycardia
Timepoint
daily during the intervention period
Method of measurement
Doctor supervision and clinical monitor

4

Description
Hypotension
Timepoint
daily during the intervention period
Method of measurement
Mercury sphygmomanometer

5

Description
Mortality rate
Timepoint
The last day of hospitalization
Method of measurement
patient file

6

Description
Duration of stay in PICU
Timepoint
The day of the patient's discharge
Method of measurement
patient file

7

Description
Re-evaluation of Ramsay score in successful patients at 6 hour later in follow-up
Timepoint
in follow-up
Method of measurement
Ramsay sedation scale

Intervention groups

1

Description
Intervention group: Dexmedomidine is injected intravenously. The bolus dose of the drug will be 0.5 micrograms per kilogram and the starting dose of the infusion will be 0.25 micrograms per kilogram per hour. While evaluating every 15 minute, if the sedation level is lower than the target level, 0.25 micrograms per kilogram per hour will be added to the drug dose at each turn, up to a maximum of 1 microgram per kilogram per hour.
Category
Treatment - Drugs

2

Description
Control group: Children from 1 month to 15 years who are under mechanical ventilation in the intensive care unit and are injected intravenously with midazolam for sedation. The bolus dose of the drug will be 0.15 mg per kilogram and the starting dose of the infusion will be 1 microgram per kilogram per minute. While evaluating every one hour, if the level of sedation is lower than the target level, 1 microgram per kilogram per minute will be added to the drug dose at each turn, up to a maximum of 4 micrograms per kilogram per minute. If we do not reach the target sedation level with the maximum dose, the treatment will be considered a failure and the second sedative drug will be added
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Majid Sezavar
Street address
Akbar Children's Hospital, Shahid Kaveh 14, Shahid Kaveh Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3870 9225
Email
sezavardm@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Majid Sezavar
Street address
Ahmadabad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3845 3239
Email
Sezavardm@mums.ac.ir

3

Recruitment center
Name of recruitment center
Sheikh Hospital
Full name of responsible person
Majid Sezavar
Street address
Dr. Sheikh Ave., Tohid Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3726 9021
Email
sezavardm@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayor Mobarhan
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant from Mashhad University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Majid Sezavar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
ِakbar hospital.Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3870 9225
Fax
Email
sezavardm@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Sezavar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Akbar Children's Hospital, Shahid Kaveh 14, Shahid Kaveh Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3870 9225
Email
sezavardm@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Sezavar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
ِakbar hospital.Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3870 9225
Fax
Email
sezavardm@mums.ac.ir

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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The main and secondary results can be shared.
When the data will become available and for how long
Six months after the results are published
To whom data/document is available
Researchers affiliated with academic centers
Under which criteria data/document could be used
Researchers affiliated with academic centers
From where data/document is obtainable
Dr.Majid Sezavar
What processes are involved for a request to access data/document
Request via email to sezavardm@mums.ac.ir
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