The effect of ketamine is compared with Dexmedetomidine in the management of pain and complications after orthopedic surgery of the lower extremities of the femur or pelvis.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 70 patients. For randomization, the necessary software for permutation blocks is used
Settings and conduct
Patients undergoing orthopedic surgery of the femur or pelvis in Vali Asr Teaching Hospital in Arak are randomly divided into two groups. The intervention group received ketamine at a dose of 1 mg / kg and the control group received dexmedetomidine at a dose of 1 μg / kg in the pain pump after orthopedic surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 65 years, orthopedic surgery of the lower limb or pelvis with general anesthesia, satisfaction with the research, absence of underlying diseases such as cardiovascular, physical condition 1 and 2 American Society of Anesthesiologists (ASA) )
Exclusion criteria: Sensitivity to ketamine or Dexmedetomidine, cardiovascular and pulmonary disease, death of patient, dissatisfaction with participation in the study, cancellation of the study at any stage.
Intervention groups
The intervention group received ketamine at a dose of 1 mg / kg and the control group received Dexmedetomidine at a dose of 1 μg / kg in the pain pump after orthopedic surgery
Main outcome variables
Comparison of postoperative pain in patients in the intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161014030294N5
Registration date:2021-01-13, 1399/10/24
Registration timing:prospective
Last update:2021-01-13, 1399/10/24
Update count:0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
Mansoreh Karimikia
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 4702
Email address
m.karimikia@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Ketamine in comparison with Dexmedetomidine dose in pain management and postoperative complications of orthopedics
Public title
Investigation of the effect of Ketamine in comparison with Dexmedetomidine dose in pain management and postoperative complications of orthopedics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
orthopedic surgery of the lower limb or pelvis with general anesthesia
consent to research
absence of underlying diseases such as cardiovascular
physical condition 1 and 2 American Society of Anesthesiologists (ASA)
Exclusion criteria:
Hypersensitivity to Ketamine or Dexmedetomidine
cardiovascular and pulmonary disease
death of patient
dissatisfaction with participation in the study
withdrawal from the study at any stage
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is done purposefully. In this study, due to the existence of two types of treatment, the block randomization method is used. Is a randomization unit of the individual. Depending on the sample size, blocks with a capacity of 4 units are considered. In order to better randomize, the web-based software is used to prepare a randomization list, which creates random permutations for each type of treatment in each block, and due to the change of permutations in each block, concealment is also observed. The researcher's ability to predict the next treatment decreases during the study.Site used for random permutation block method: https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who have undergone orthopedic surgery of the lower extremities of the femur or pelvis are included in the study by easy sampling. Patients are randomly divided into two groups of 35 people. Group 1 receives a pain pump containing Ketamine labeled A and group 2 receives a pain pump containing Dexmedetomidine labeled B. The preparation of the pain pump is done by someone outside the study and the caregiver does not know the type of medicine inside the pain pump.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.ARAKMU.REC.1399.256
Health conditions studied
1
Description of health condition studied
Femoral orthopedic surgery
ICD-10 code
s72
ICD-10 code description
femoral fracture
Primary outcomes
1
Description
The extent of postoperative pain
Timepoint
Pain score before the intervention and after up to 8 hours after the operation every hour
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They receive ketamine at a dose of 1 mg / kg in the pain pump after the operation. Complications and pain scores are observed before the intervention and after 8 hours after the operation in the recovery and transferred ward.
Category
Treatment - Drugs
2
Description
Control group: They receive dexmedetomidine at a rate of 1 microgram per kilogram in the pain pump after the operation. Observation of complications and pain score before the intervention and after 8 hours after the operation is performed every hour in the recovery and transferred ward.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali Asr Hospital in Arak
Full name of responsible person
Behnam Mahmoudieh
Street address
Vali Asr Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2004
Fax
+98 86 3223 1283
Email
Behnammahmoudye@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
a.kamali@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Mansoreh Karimi Kia
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
karimikia93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Behnam Mahmoudieh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
Behnammahmoudye@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mansoreh Karimi Kia
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
karimikia93@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period 2 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use documentation by citing the source
From where data/document is obtainable
Mansoreh Karimi Kia Arak University of Medical Sciences Phone 09181600717 Email karimikia93@gmail.com
What processes are involved for a request to access data/document
After receiving the request by phone or email, the data will be sent within 2 weeks.