Comparison of addition of midazolam; fentanyl and magnesium sulfate to intrathecal bupivacaine on block characteristics and analgesia in knee arthroplasty
Comparison of addition of midazolam and fentanyl and magnesium sulfate to intrathecal bupivacaine on block characteristics and analgesia in knee arthroplasty
Design
The double blind randomized clinical trial, consisted of 105 patients who are randomly divided into 3 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
The study population are patients with knee arthroplasty surgery in valiasr hospital in Arak who are divided into 3 groups by simple randomization using envelopes. The study is double-blind in which outcome evaluator, data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 18 to 60 years, ASA class 1 and 2, Patients who are candidates for knee replacement surgery.
Non-inclusion criteria: The patient refuses to perform spinal anesthesia, failure to perform spinal anesthesia, local infection in the spinal part, peripheral and central neuropathy, mental health problems, arrhythmia.
Intervention groups
Intervention group1 : We will inject Midazolam at the dose of 2 milligram and hyperbar bupivacaine 0.5% at the dose of 15 milligram.
Intervention group 2: We will inject Fentanyl at the dose of 50 micrograms with hyperbar bupivacaine 0.5% at the dose of 15 milligram.
Intervention group3: We will inject magnesium sulfate at the dose of 100 milligram with hyperbar bupivacaine 0.5% at the dose of 15 milligram.
Main outcome variables
Duration of sensory block, duration of motor block, pain, mean analgesic drug, heart rate, blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N164
Registration date:2021-08-04, 1400/05/13
Registration timing:registered_while_recruiting
Last update:2021-08-04, 1400/05/13
Update count:0
Registration date
2021-08-04, 1400/05/13
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of addition of midazolam; fentanyl and magnesium sulfate to intrathecal bupivacaine on block characteristics and analgesia in knee arthroplasty
Public title
Effect of midazolam, fentanyl and magnesium sulfate to on analgesia in knee arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 18 to 60 years
ASA class 1 and 2
Patients who are candidates for knee replacement surgery
Exclusion criteria:
The patient refuses to perform spinal anesthesia
Failure to perform spinal anesthesia
Local infection in the spinal part
Peripheral and central neuropathy
Mental health problems
Arrhythmia
Coagulation disorders
Cardiovascular problems
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 3 groups A and B and C.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij square ,Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-12-06, 1399/09/16
Ethics committee reference number
IR.ARAKMU.REC.1399.258
Health conditions studied
1
Description of health condition studied
Knee arthroplasty
ICD-10 code
Z96.65
ICD-10 code description
Presence of artificial knee joint
Primary outcomes
1
Description
Sensory block duration
Timepoint
After surgery
Method of measurement
Chronometer
2
Description
Motor block duration
Timepoint
After surgery
Method of measurement
Chronometer
3
Description
Pain
Timepoint
Recovery and 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Visual analog pain questionnaire
4
Description
Mean of opiate drug use
Timepoint
24 hours after surgery
Method of measurement
Milligram
5
Description
Mean blood pressure
Timepoint
Recovery and 2, 4 and 6 hours after surgery
Method of measurement
Sphygmomanometer
6
Description
Mean heart rate
Timepoint
Recovery and 2, 4 and 6 hours after surgery
Method of measurement
Count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1 : We will inject Midazolam at the dose of 2 milligram and hyperbar bupivacaine 0.5% at the dose of 15 milligram.
Category
Treatment - Drugs
2
Description
Intervention group 2: We will inject Fentanyl at the dose of 50 micrograms with hyperbar bupivacaine 0.5% at the dose of 15 milligram.
Category
Treatment - Drugs
3
Description
Intervention group 3: We will inject magnesium sulfate at the dose of 100 milligram with hyperbar bupivacaine 0.5% at the dose of 15 milligram
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Deputy, Payambar Azam Complex, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Esmaeel Moshiri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital; Valiasr square; Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
modir.he@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr hospital; Valiasr square; Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Tayebe Sadat Sayafi Sharifi
Position
Medicine student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Payambar Azam Complex, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
he.modir@hotmail.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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