Comparison of the analgesia effect of Dexmedetomidine with Fentanyl, in combination with Marcaine in femoral neck fracture surgery with spinal anesthesia
Determining and comparing the analgesia effect of Dexmedetomidine with Fentanyl, in combination with Marcaine in femoral neck fracture surgery with spinal anesthesia, in medical centers-hospital of Qazvin University of Medical Sciences.
Design
A double-blind clinical trial with a control group, with parallel groups, non-random allocation, phase 3, the number of 25 samples in each group is estimated. Allocation of samples to intervention groups is done based on doctor's diagnosis
Settings and conduct
This study is conducted in patients with femoral neck fractures referred to Rajai educational and therapeutic centers who are candidates for femoral neck fracture surgery according to the order of the orthopedic surgeon.With the doctor's diagnosis the patient entered one of the three test groups A (Marcaine-Fentanyl), the experiment B (Marcaine-Dexmedtomidine) and control group (placebo). The dose of drugs is: (25μg/kg Fentanyl), (2.5mg/kg Marcaine) and (5μg/kg Dexmedetomidine)
The participant and outcome evaluator are blind
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged 45 to 75 who come to Shahid Rajaei Hospital with a complaint of femoral neck fracture
exclusion criteria:
Taking corticosteroids, antihistamines and painkillers for a long time
Hypersensitivity to marcaine, fentanyl and dexmedetomidine
Intervention groups
Test group A (Marcaine - Fentanyl), Test group B (Marcaine - Dexmedtomidine) and control group (placebo)
Dosage of drugs: Fentanyl 25μg/kg, Marcaine 2.5mg/kg and Dexmedetomidine 5μg/kg
Main outcome variables
The amount and intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230805059046N1
Registration date:2023-09-03, 1402/06/12
Registration timing:registered_while_recruiting
Last update:2023-09-03, 1402/06/12
Update count:0
Registration date
2023-09-03, 1402/06/12
Registrant information
Name
Paria Talebnezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
paria.talebnezhad8898@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesia effect of Dexmedetomidine with Fentanyl, in combination with Marcaine in femoral neck fracture surgery with spinal anesthesia
Public title
"Comparison of the effect of Dexmedetomidine + Marcaine with Fentanyl + Marcaine in femur fracture surgery"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research with informed consent after giving necessary and sufficient explanations about the study
The person's age should be between 45 and 75 years
No history of surgery
No history of smoking, alcohol and drugs
Not having chronic physical or mental illness (schizophrenia, diabetes, etc.)
Not having vision and hearing problems and other disabilities
Not using corticosteroids, antihistamines, narcotics and painkillers for a long time
Lack of allergy to marcaine, fentanyl and dexmedomidine
Absence of pregnancy, breastfeeding and abortion less than 3 months
Exclusion criteria:
Unwillingness to cooperate in the study
Occurrence of any problems and complications during the study
The diagnosis of the surgeon or other specialists to withdraw from the study
Heart diseases and HTN
Liver diseases (cirrhosis, hepatitis, etc.)
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind type of experiment, which will be blind for the people participating in the study and evaluating the outcome. In the consent form to participate in the study, it is written for the patient that his presence does not necessarily mean intervention but may be included in the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of qazvin University of Medical Sciences
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.QUMS.REC.1400.489
Health conditions studied
1
Description of health condition studied
Femoral neck fracture surgery
ICD-10 code
S72.0
ICD-10 code description
Fracture of head and neck of femur
Primary outcomes
1
Description
The amount and intensity of pain
Timepoint
3, 6 and 12 hours after the operation
Method of measurement
Using a ruler-like grading system (Visual Analog Scale) from 0 (no pain) to 10 (the most severe pain imaginable)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: (25 μg/kg Fentanyl from Caspian Tamin Pharmaceutical Company and 2.5 mg/kg Marcaine from Adorateb Pharmaceutical Company). After patients enter the operating room, anesthesia is started with spinal anesthesia, and the anesthesiologist starts prescribing Marcaine-Fentanyl.
Category
Treatment - Drugs
2
Description
Intervention group B: (5μg/kg Dexmedetomidine from Exir Pharmaceutical Company and 2.5mg/kg Marcaine from Adorateb Pharmaceutical Company). After patients enter the operating room, anesthesia is started with spinal anesthesia and the anesthesiologist prescribes Markain-Dexmedetomidine.
Category
Treatment - Drugs
3
Description
Control group: Routine hospital anesthesia method (2.5mg/kg Marcaine from Adorateb Pharmaceutical Company). After patients enter the operating room, anesthesia is started with spinal anesthesia and the anesthesiologist prescribes Markain
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Paria Talebnezhad
Street address
Safdari Ave., Padegan Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 5800
Email
Paria.Talebnezhad8898@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Paria Talebnezhad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
Paria.Talebnezhad8898@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
PariaTalebnezhad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
University campus building, Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
Paria.Talebnezhad8898@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Paria Talebnezhad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
University campus building, Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
Paria.Talebnezhad8898@gmail.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