Determining and comparing the effect of administration of dexmedetomidine and magnesium sulfate in controlling bleeding in lumbar laminectomy surgery
Design
A randomized, double-blinding clinical trial, with the parallel groups, Phase 2-3 on 62 patients
Settings and conduct
In this randomized double-blind clinical trial study, 62 eligible patients referred to Kashani and Al-Zahra Hospital in Isfahan will be included in the study and will be randomly divided into two groups. In this study, the patient and the researcher will not have any knowledge about the type of intervention. Then the hemodynamic parameters and incidence of complications of the patients will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria: the indication of lumbar fusion; the age group of 18 to 60 years. Exclusion criteria: having heart diseases (arrhythmias, heart valve diseases, uncontrolled hypertension); history of respiratory diseases; history of preoperative coagulation disorders; history of hepatitis and kidney failure; history of diabetes mellitus; history of neuromuscular diseases; history of seizures; being allergic to any of the drugs used in the study.
Intervention groups
In the first intervention group, after induction of general anesthesia, 60 mg/kg of magnesium sulfate diluted 50% in 100 cc of normal saline is injected intravenously within 15 minutes.
In the second intervention group, dexmedetomidine infusion is started before anesthesia with a dose of 1 μg/kg every 10 minutes. Dexmedetomidine infusion at a rate of 0.5 μg/kg/hour continues until the end of surgery.
Main outcome variables
Systolic blood pressure; Diastolic blood pressure; Mean arterial pressure; Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N59
Registration date:2024-07-16, 1403/04/26
Registration timing:prospective
Last update:2024-07-16, 1403/04/26
Update count:0
Registration date
2024-07-16, 1403/04/26
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2025-03-21, 1404/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of dexmedetomidine and magnesium sulfate administration in controlling bleeding in lumbar laminectomy surgery
Public title
The effect of dexmedetomidine and magnesium sulfate in controlling bleeding in lumbar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having indication of lumbar fusion
Age 18 to 60 years
Exclusion criteria:
Having heart diseases (arrhythmias, heart valve diseases, uncontrolled hypertension)
History of respiratory diseases
History of preoperative coagulation disorders
History of hepatitis
History of kidney failure
History of diabetes mellitus
History of neuromuscular diseases
History of seizures
Being allergic to any of the drugs used in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 62 eligible patients are randomly selected. Then the letter A is written on 31 sheets and the letter B is written on 31 sheets, and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to achieve the double-blind study, two drugs, dexmedetomidine and magnesium sulfate, are prepared daily by the operating room nurse (without the researcher's awareness) before the operation and placed in the bag and will be labeled A and B. And is given daily to the anesthesiologist (researcher). Therefore, the patient, the Investigator, the person recording the clinical and basic information of the patients will not be aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.MUI.MED.REC.1403.093
Health conditions studied
1
Description of health condition studied
lumbar fusion surgery
ICD-10 code
M43.26
ICD-10 code description
Fusion of spine, lumbar region
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Before induction and then every 30 minutes until the end of surgery
Method of measurement
Monitoring device
2
Description
Diastolic blood pressure
Timepoint
Before induction and then every 30 minutes until the end of surgery
Method of measurement
Monitoring device
3
Description
Mean arterial pressure
Timepoint
Before induction and then every 30 minutes until the end of surgery
Method of measurement
Monitoring device
4
Description
Bleeding
Timepoint
During surgery
Method of measurement
BOEZAAL Scale
Secondary outcomes
1
Description
Tachycardia
Timepoint
During surgery
Method of measurement
Monitoring device (30% increase in heart rate compared to baseline)
2
Description
Bradycardia
Timepoint
During surgery
Method of measurement
Monitoring device (30% decrease in heart rate compared to baseline)
3
Description
Hypertension
Timepoint
During surgery
Method of measurement
Monitoring device (30% increase in mean arterial pressure compared to baseline)
Intervention groups
1
Description
First intervention group: In this group, after induction of general anesthesia, 60 mg/kg of magnesium sulfate diluted 50% in 100 cc of normal saline is injected intravenously within 15 minutes. As the starting dose of injection, it is continued at a rate of 5 g/h (20 g in 100 cc of normal saline) until 30 minutes before the end of the operation and achieving an average arterial pressure of 55 to 60 mm Hg.
Category
Treatment - Drugs
2
Description
Second intervention group: In this group, dexmedetomidine infusion is started before anesthesia with a dose of 1 microgram/kg every 10 minutes. Dexmedetomidine infusion at a rate of 0.5 μg/kg/hour continues until the end of the surgical procedure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahara hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulivard, Shahid Kesari highway
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Behzad Nazemoroaya
Street address
Kashani street
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Assistant Professor/Faculty
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospital, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
behzad_nazem@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Behzad Nazemroaya
Position
Assistant Professor/Faculty
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospital, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
behzad_nazem@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Negar Meshkin
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospital, Sefeh Blvd., Tohid Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
Email
negarmesh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD