Comparative effect of ketamine and magnesium sulfate on pain control after spine surgery.
Design
Clinical trial with 2 interventional group, Block randomization, 43 subjects in each group, with parallel groups, double blind
Settings and conduct
Sampling is simple randomization. The letter A belongs to the magnesium sulfate group with an initial dose of 50 mg / kg and the letter B belongs to the ketamine group with an initial dose of 0.5 mg / kg. This process will continue until 36 people are selected for each group. Anesthesia induction will be performed by an anesthesiologist who is aware of the design and has no role in the process and outcome of the study. The patient's hemodynamics will be recorded in the operating room throughout the surgery, and the time of onset of pain and the first dose received and pain will be recorded based on the VAS.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Class 1 or 2 ASA ، Age range 18-65 years
،Candidate for laminectomy by posterior lumbar spine CD. Exclusion criteria: Previous history of lumbosacral surgery، History of schizophrenia and use of antipsychotic drugs، History of calcium channel blockers، History of neuropathy and myopathy، History of kidney damage requires dialysis in the past، Presence of conduction system abnormalities in the ECG taken from the patient، History of ketamine allergy، The length of stay after surgery is less than 48 hours.
Intervention groups
First group: Magnesium sulfate 50 mg/kg by infusion over 20 minutes;Magnesium sulfate 500 mg/hr as an infusion in a pain pump lasts up to 48 hours after surgery. Second group: ketamine 0.5 mg/kg in bolus 2 minutes before surgical incision; Ketamine 2.5 µ /kg/hr as an infusion in a pain pump lasts up to 48 hours after surgery.
Main outcome variables
Determining the mean score of postoperative pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170413033408N6
Registration date:2021-03-11, 1399/12/21
Registration timing:registered_while_recruiting
Last update:2021-03-11, 1399/12/21
Update count:0
Registration date
2021-03-11, 1399/12/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 9891
Email address
dr.mojaveraghili@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-23, 1399/12/05
Expected recruitment end date
2022-02-24, 1400/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of ketamine and magnesium sulfate on pain control after spine surgery.
Public title
Comparison of the effect of ketamine and magnesium sulfate on pain control after spinal surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Class 1 or 2 ASA based on the physical condition of the American Anesthesia Association.
Subjects in the age range of 18-65 years.
Candidate for laminectomy and discectomy and screw and plaque implantation by posterior lumbar and sacral spine CD.
Exclusion criteria:
Previous history of lumbosacral surgery.
History of schizophrenia and use of antipsychotic drugs.
History of calcium channel blockers.
History of neuropathy and myopathy.
History of kidney damage requires dialysis in the past.
Presence of conduction system abnormalities in the ECG taken from the patient.
History of ketamine allergy.
The length of stay after surgery is less than 48 hours.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
How to assign patients to one of the two drug groups will be done based on the permutation block method. A random sequence of letters A and B will be generated in 18 quadruple blocks and will be provided to one of the members of the research team. This member will not interfere in the selection of samples. The letter A belongs to the magnesium sulfate group and the letter B belongs to the ketamine group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Anesthesia induction will be performed by a design-conscious anesthesiologist who will have no role in the process and outcome of the study, and the preparation of pumps that are similar in appearance (size, shape, volume, manufacturer)
will be performed by the recovery nurse and the physician in charge will have no information about its contents and will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Gorgan, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2021-01-24, 1399/11/05
Ethics committee reference number
IR.GOUMS.REC.1399.343
Health conditions studied
1
Description of health condition studied
Candidate for laminectomy and discectomy and screw and plaque implantation by posterior lumbar and sacral spine CD
ICD-10 code
M96.1
ICD-10 code description
Postlaminectomy syndrome, not elsewhere classified
2
Description of health condition studied
Spondylopathies
ICD-10 code
M45-M49
ICD-10 code description
Spondylopathies
Primary outcomes
1
Description
Postoperative pain score
Timepoint
Pain score since entering recovery,6, 12, 24, 36 and 48 hours after surgery will be measured.
Method of measurement
Based on VAS measurement criteria
2
Description
Postoperative sedation rate
Timepoint
Sedation score since entering recovery,6, 12, 24, 36 and 48 hours after surgery will be measured.
Method of measurement
Based on RSS measurement criteria
3
Description
hemodynamic changes
Timepoint
The patient's hemodynamic monitoring will be performed from the time of entering the operating room until the end of the operation.
Method of measurement
Hemodynamic criteria (heart rate, systolic, diastolic, and mean arterial blood pressure (MABP), arterial oxygen saturation) of the patient will be measured by Saadat monitoring.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Magnesium sulfate 50 mg / kg by infusion with CVE = 5 ml / kg over 20 minutes; Magnesium sulfate 500 mg / hr as an infusion in a pain pump lasts up to 48 hours after surgery.
Category
Treatment - Drugs
2
Description
Intervention group: ketamine 0.5 mg / kg in bolus form immediately after patient positioning and 2 minutes before surgical incision; Ketamine 2.5 µ / kg / hr as an infusion in a pain pump lasts up to 48 hours after surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gorgan 5 Azar Educational and Medical Center
Full name of responsible person
Seyed Babak Mojaver Aghili
Street address
Gorgan-Sari road 4th kilometers, Golestan University of Medical Sciences, School of Medicine - Anesthesiology Department
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
+98 17 3223 8363
Email
drbabaka35@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Reza Honarvar
Street address
Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Golestan, Iran
City
Gorgan
Province
Golestan
Postal code
49341-74515
Phone
+98 17 3253 8011
Email
honarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Seyed Babak Mojaver Aghili
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Golestan, Iran
City
Gorgan
Province
Golestan
Postal code
49341-74515
Phone
+98 17 3253 8011
Email
drbabaka35@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyed Babak Mojaver Aghili
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Golestan, Iran
City
Gorgan
Province
Golestan
Postal code
49341-74515
Phone
+98 17 3253 8011
Email
drbabaka35@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyed Babak Mojaver Aghili
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Golestan, Iran
City
Gorgan
Province
Golestan
Postal code
49341-74515
Phone
+98 17 3253 8011
Email
drbabaka35@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
Since 2020
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
No manipulation, mentioning the data reference
From where data/document is obtainable
Seyed Babak Mojaver Aghili, drbabaka35@gmail.com, Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology, Gorgan, Golestan, Iran.
What processes are involved for a request to access data/document
sending an email, complete the personal and professional characteristics with documentation