Evaluation of magnesium sulfate efficacy in reducing sedative requirement in patients under mechanical ventilation
Design
This is a double-blinded, randomized clinical trial. Eligible patients will be assigned to one of the groups of the study according the permuted block randomization.
Settings and conduct
This double-blind randomized clinical trial is designed in Imam Khomeini Hospital Complex. Patients in the ICU requiring mechanical ventilation support for more than 48 hours will include. Sedation of patients will be done based on the protocol. The amount of sedative drugs required for each patient is determined based on the Richmond Agitation Sedation Scale (RASS) tool. Patients in addition to designed sedation protocol, will receive magnesium sulfate or placebo. The study duration is 48hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult patients in ICU who need mechanical ventilation support for at least 48 hours
Exclusion criteria: History of allergic reactions to magnesium sulfate or chronic renal failure
Intervention groups
Control group: In addition to the sedation protocol, patients will be treated with placebo (saline).
Intervention group: In addition to the sedation protocol, patients will receive intravenous infusion of magnesium sulfate. The target serum level of magnesium in this group is 3mg/dL. The dose of magnesium for each patient will be based on the rule of thumb. The one third of the calculated dose will be infused as a bolus within 30 minutes and the rest within 24 hours.
Main outcome variables
24 and 48 hours cumulative dose of intravenous opioid
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100228003449N33
Registration date:2024-12-11, 1403/09/21
Registration timing:registered_while_recruiting
Last update:2024-12-11, 1403/09/21
Update count:0
Registration date
2024-12-11, 1403/09/21
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-01, 1403/09/11
Expected recruitment end date
2025-06-01, 1404/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of magnesium sulfate efficacy in reducing sedative requirement in patients under mechanical ventilation
Public title
Magnesium sulfate and reducing sedative requirement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in ICU who required mechanical ventilation for at least 48 hours
Exclusion criteria:
Patients with a history of allergic reactions to intravenous magnesium sulfate
Patients who need deep sedation (RASS≥-4)
Patients with any brain damage
Patients with myasthenia gravis
Patients with chronic renal failure (eGFR less than 30 ml/min)
Pregnant and lactating women
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by the method of random blocks. According to the sample size, four patients are included in each block. Random groups are AABB, BBAA, ABBA, ABAB, BABA, BAAB. Random numbers will be generated by Excel software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Intravenous magnesium sulfate and saline will be prepared and labeled by a technician not involved in the study. The patient and research members are unaware of the contents of the syringes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University Of Medical Sciences
Street address
Ghods Ave. Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2024-10-27, 1403/08/06
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.143
Health conditions studied
1
Description of health condition studied
Management of pain, agitation/sedation and delirium in mechanically ventilated patients
ICD-10 code
F13
ICD-10 code description
Sedative, hypnotic, or anxiolytic related disorders
Primary outcomes
1
Description
Cumulative dose of required intravenous opioid
Timepoint
At the end of 24 and 48 hours
Method of measurement
Based on fentanyl dose or equivalent dose of other registered opioids
Secondary outcomes
1
Description
Required adjuvant sedative drugs
Timepoint
At the end of 24 and 48 hours
Method of measurement
Based on the registered drug and cumulative dosage
2
Description
Required analgesic drugs
Timepoint
At the end of 24 and 48 hours
Method of measurement
Based on the registered drug and cumulative dosage
3
Description
Duration of respiratory support
Timepoint
Daily
Method of measurement
Patient follow-up
4
Description
Duration of ICU stay
Timepoint
Daily
Method of measurement
Patient follow-up
5
Description
28-day mortality
Timepoint
28 days after starting the intervention
Method of measurement
Patient follow-up
6
Description
Safety of intravenous magnesium sulfate
Timepoint
Continuous monitoring during the study period
Method of measurement
Patient follow-up
7
Description
Change in serum CRP level
Timepoint
48 hours after starting the intervention
Method of measurement
Laboratory data
Intervention groups
1
Description
Control group: In addition to the sedation protocol, patients will receive placebo (saline).
Category
Placebo
2
Description
Intervention group: In addition to the sedation protocol, patients will receive intravenous magnesium sulfate. The target serum level of magnesium in this group is 3 mg/dL. The dose of magnesium for each patient will be calculated based on the rule of thumb. According to this rule, every 1 gram of magnesium sulfate leads to an increase of 0.18 mg/dL in the serum level of magnesium. One third of the calculated dose will be infused as a bolus within 30 minutes and the rest within 24 hours. Each 1 gram of intravenous magnesium sulfate will be diluted in 50 ml of normal saline and infused at least within 1 hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
02166706141
Phone
+98 21 8898 7381
Email
ramin_kordi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1427614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6695 4715
Email
khalilih@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
The results of the study will be published as an article. The study protocol and statistical analyzes used in the article will be included.
When the data will become available and for how long
One year after finishing the study, the data will be published and will be available in databases.
To whom data/document is available
After permission from the sponsor, data of the study will be available for academic researchers, physicians and scientific institutes.
Under which criteria data/document could be used
Other researchers are permitted to included the results in their systematic reviews and meta analysis.
From where data/document is obtainable
For this you may ask Hossein Khalili through following information: Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran Postal code: 1417614411- E-mail: khalilih@tums.ac.ir
What processes are involved for a request to access data/document
After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with sponsor within 2 weeks.