Comparison of Dexmedetomidine and Fentanyl effect in change of hemodynamic response and block characters after spinal anesthesia with Ropivacaeen in lower limb fracture
Comparison of Dexmedetomidine and Fentanyl effect in change of hemodynamic response and block characters after spinal anesthesia with Ropivacaeen in lower limb fracture
Design
This study is clinical trial and double blind. patients will be divided in 2 groups by simple randomization.Groups are parallel.
Settings and conduct
Patients candidate for femoral orthopedic surgery in Valiasr hospital in Arak will enter this study. Outcome assessor and analyzer don't aware from grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:ASA class 1 and 2, patients undergoing femoral orthopedic surgery, failure to perform spinal anesthesia, no history of taking beta-blockers and alpha-2 calcium channel blockers and blockers, lack of cardiovascular problems, no pregnancy, absence of coagulation disorders
Exclusion criteria:patient dissatisfaction, blocks failed, surgical operations more than 120 minutes, patients who have heart-respiratory arrhythmia during operation
Intervention groups
First group: injection of 5 microgram Dexmedetomidine plus 3-4 milliliter Ropivacaeen (15-20 milligram) (Hospira Co.America).
Second group: injection of 20 microgram Fentanyl plus 3-4 milliliter Ropivacaeen (15-20 milligram) (Hospira Co.America).
Main outcome variables
blood pressure; heart rate; oxygen saturation; pain; duration of motor and sensory block; narcotic drug consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N115
Registration date:2019-07-07, 1398/04/16
Registration timing:registered_while_recruiting
Last update:2019-07-07, 1398/04/16
Update count:0
Registration date
2019-07-07, 1398/04/16
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
2019-04-21, 1398/02/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dexmedetomidine and Fentanyl effect in change of hemodynamic response and block characters after spinal anesthesia with Ropivacaeen in lower limb fracture
Public title
Comparing the effect of Dexmedetomidine and Fentanyl in change of hemodynamic response and block characters after spinal anesthesia with Ropivacaeen in lower limb fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class 1 and 2
Patients undergoing femoral orthopedic surgery
Lack of failure to perform spinal anesthesia
No history of taking beta-blockers and alpha-2 calcium channel blockers and blockers
Lack of cardiovascular problems
No pregnancy
Absence of coagulation disorders
Non-localized infection in the spinal cord
Absence of mental and psychological problems
Lack of peripheral and central neuropathy
Exclusion criteria:
Patient dissatisfaction
Blocks failed
Surgical operations more than 120 minutes
Patients who have heart-respiratory arrhythmia during operation
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:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two groups A and B .
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 double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
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 squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-04-07, 1398/01/18
Ethics committee reference number
IR.ARAKMU.REC.1398.028
Health conditions studied
1
Description of health condition studied
Femure fracture
ICD-10 code
S72.0
ICD-10 code description
Fracture of neck of femur
Primary outcomes
1
Description
Mean arterial blood pressure
Timepoint
In the first 15 minutes every 5 minutes, then at minutes 30, 60, 45, 90
Method of measurement
Barometer
2
Description
Heart rate
Timepoint
In the first 15 minutes every 5 minutes, then at minutes 30, 60, 45, 90
Method of measurement
Count
3
Description
Percent of oxygen saturation
Timepoint
In the first 15 minutes every 5 minutes, then at minutes 30, 60, 45, 90
Method of measurement
Pulse oximetry
4
Description
Duration of motor block
Timepoint
Every 5 minute
Method of measurement
Minute
5
Description
Duration of Sensory block
Timepoint
Every 5 minutes
Method of measurement
Minute
6
Description
Pain
Timepoint
At recovery and 2 and 4 and 8 postoperative
Method of measurement
Visual Analogue Scale Questionnaire
7
Description
Mean of narcotic
Timepoint
24 hour after surgery
Method of measurement
Milligram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: We inject 5 microgram Dexmedetomidine plus 3-4 milliliter Ropivacaeen(15-20 milligram)(Hospira Co.America).
Category
Treatment - Drugs
2
Description
Intervention group2: We inject 20 microgram Fentanyl plus 3-4 milliliter Ropivacaeen(15-20 milligram)(Hospira Co.America).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Alireza Kamali
Street address
Valiasr Hospital, Arak
City
Arak
Province
Markazi
Postal code
848176941
Phone
+98 86 3222 2003
Email
alikamaliir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@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
Dr Shirin Pazuki
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
pazuki@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street