Comparison of two drugs, midazolam, and dexmedetomidine, in the sedation of children under mechanical ventilation
Design
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.
Settings and conduct
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).
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 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.
Main outcome variables
The rate of treatment failure and the need for a second sedative drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190522043672N3
Registration date:2023-02-16, 1401/11/27
Registration timing:registered_while_recruiting
Last update:2023-02-16, 1401/11/27
Update count:0
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
A comparative evaluation of two drugs, midazolam, and dexmedetomidine, on the sedation of mechanically ventilated children
Public title
The effects 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
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
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 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.
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 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
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