Protocol summary
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Study aim
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Comparison of dexmedetomidine and magnesium sulfate infusion on the stability of hemodynamic status during orthopedic surgery in obese people
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Design
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In this double-blind clinical trial study (participants and results analyzer), patients will undergo surgery after random allocation in the four mentioned groups. For two groups (obese and non-obese (emergency surgery candidate )), dexmedetomidine will be injected intravenously, and for the other two groups (obese and non-obese (emergency surgery candidate )), magnesium sulfate will be injected intravenously, and the hemodynamic status of the four groups will be compared.
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Settings and conduct
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This study was conducted as a randomized clinical trial (blocks of four), double-blind (participants and results analyzer), with parallel groups, without a control group, and with the participation of 180 orthopedic surgery patients referred to Imam Reza Hospital (Tabriz). will be.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: candidate for orthopedic surgery and consent to participate in the research project and exclusion criteria: sensitivity to study drugs and changes in hemodynamic status during anesthesia will be more than 40 %.
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Intervention groups
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In this study, patients who will refer to the operating room for orthopedic surgery will be subjected to intervention. Patients will be randomly divided into four groups. For two groups (obese and non-obese people (emergency surgery candidate ) ), dexmedetomidine will be injected intravenously, and for the other two groups (obese and non-obese people (emergency surgery candidate )), magnesium sulfate will be injected intravenously. The hemodynamic status during surgery will be compared between the four groups.
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Main outcome variables
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Hemodynamic status
General information
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Reason for update
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Inclusion criteria/exclusion criteria for two groups of incompletely entered participants.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190325043107N46
Registration date:
2024-05-03, 1403/02/14
Registration timing:
retrospective
Last update:
2024-06-24, 1403/04/04
Update count:
1
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Registration date
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2024-05-03, 1403/02/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-01-01, 1399/10/12
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Expected recruitment end date
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2022-12-30, 1401/10/09
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Actual recruitment start date
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2023-01-04, 1401/10/14
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Actual recruitment end date
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2023-01-04, 1401/10/14
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Trial completion date
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2023-01-04, 1401/10/14
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Scientific title
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Comparison of dexmedetomidine and magnesium sulfate infusion on the stability of hemodynamic status during orthopedic surgery in obese people
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Public title
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Infusion of dexmedetomidine and magnesium sulfate on the stability of hemodynamic status
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Candidate for orthopedic surgery
Consent to participate in the research project
Exclusion criteria:
Allergy to study drugs
Hemodynamic status changes during anesthesia more than 30%
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Age
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From 40 years old to 75 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
160
Actual sample size reached:
160
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be divided into one of four research groups using block randomization technique. To achieve this goal, a total of 40 blocks will be used, and each block will contain an equal number of people from all four study groups. The sequence of these blocks will be determined by random lottery and depending on the block assigned to it, patients in group D1 (dexmedetomidine group and obese patients), group D2 (dexmedetomidine group and non-obese patients), group M1 (sulfate group) magnesium and obese patients) and M2 (magnesium sulfate group and non-obese patients) will be categorized.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The person who was responsible for documenting the data and recording the results in the data collection form will be unaware of the patient grouping during the study. Subsequently, the collected data will be provided to an independent statistician independent of the research team, who will also be kept in the dark about the groupings. Consequently, the present study follows a double-blind research design.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-12-26, 1400/10/05
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Ethics committee reference number
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IR.TBZMED.REC.1400.998
Health conditions studied
1
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Description of health condition studied
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Hemodynamic status
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ICD-10 code
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T84
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ICD-10 code description
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Complications of internal orthopedic prosthetic devices, implants and grafts
Primary outcomes
1
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Description
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Hemodynamic status
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Timepoint
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From three minutes before surgery to the first half hour of surgery, once every three minutes
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Method of measurement
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Monitoring and measurement of hemodynamic status
Intervention groups
1
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Description
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Intervention group: This group will be made up of obese people. These patients will receive an infusion of half a microgram per kilogram per hour half an hour before surgery, and their hemodynamic status (heart rate and non-invasive blood pressure) will be measured.
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Category
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Prevention
2
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Description
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Control group: This group will be non-obese candidates for emergency surgery. These patients will receive an infusion of half a microgram per kilogram per hour half an hour before surgery, and their hemodynamic status (heart rate and non-invasive blood pressure) will be measured.
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Category
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Prevention
3
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Description
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Intervention group: This group will be made up of obese people. These patients will receive 50 mg of magnesium sulfate half an hour before anesthesia, and their hemodynamic status (heart rate and non-invasive blood pressure) will be measured.
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Category
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Prevention
4
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Description
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Control group: This group will be non-obese candidates for emergency surgery. These patients will receive 50 mg of magnesium sulfate half an hour before anesthesia, and their hemodynamic status (heart rate and non-invasive blood pressure) will be measured.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All data will potentially be shareable after de-identifying individuals.
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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Our data will only be available to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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Use of our data after publication is permitted by citing our clinical trial code and referencing the published article.
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From where data/document is obtainable
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People can refer to the email in the article and the Eblini trial site and request information.
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What processes are involved for a request to access data/document
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The applicant must communicate with us through email and tell us which data he wants so that we can provide them.
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Comments
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