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Comparison of the effect of adding Dexmedetomidine, Granisetron and Nitroglycerin to Rupivacaine in Reducing Pain and Hemodynamic Changes in intravenous regional anesthesia of forearm surgery

Protocol summary

Study aim
Comparison of the effect of adding Dexmedetomidine, Granisetron and Nitroglycerin to Rupivacaine in Reducing Pain and Hemodynamic Changes in intravenous regional anesthesia of forearm surgery
Design
This study is clinical trial and double blind. patients will be divided in 4 groups by simple randomization.Groups are parallel.
Settings and conduct
Patients candidate for forearm surgery in Valiasr hospital in Arak will enter this study. This study is double blind. Researcher who complete questionnaire and analyzer and participant are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria:Both of gender, 20 to 65 years, candidate forearm surgery, ASA class I and II Exclusion criteria: Rinod's disease, sickle cell anemia, history of allergy to the drugs used in the study, affected limb cyanosis, drugs and psychotropic use, there is more than one body fracture or surgery, pregnancy, chronic pain, syndrome neurological disorders in the hand, hypertension-related disease and heart erythema and heart failure
Intervention groups
Dexmedetomidine group:we will inject 0/5 micro gram in kilogram co.Dexmedetomidine (Exir Co.Iran) plus 35 milliliter Rupivacaine 0/2%(Molteni Co.Italia) Granisetron group: we will inject 2 milligram Granisetron(Caspian Co.Iran) plus 35 milliliter Rupivacaine 0/2%(Molteni Co.Italia) Nitroglycerin group: we will inject 200 micro gram Nitroglycerin (Caspian Co.Iran) plus 35 milliliter Rupivacaine 0/2%(Molteni Co.Italia) Control group: we will inject 5 milliliter normal saline plus 35 milliliter Rupivacaine 0/2%(Molteni Co.Italia)
Main outcome variables
Sensory block duration, motor block duration, mean drug use, pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N123
Registration date: 2019-11-02, 1398/08/11
Registration timing: registered_while_recruiting

Last update: 2019-11-02, 1398/08/11
Update count: 0
Registration date
2019-11-02, 1398/08/11
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
2019-07-23, 1398/05/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adding Dexmedetomidine, Granisetron and Nitroglycerin to Rupivacaine in Reducing Pain and Hemodynamic Changes in intravenous regional anesthesia of forearm surgery
Public title
Comparison of the effect of adding Dexmedetomidine, Granisetron and Nitroglycerin to Rupivacaine in Reducing Pain and Hemodynamic Changes in intravenous regional anesthesia of forearm surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both of gender 20 to 65 years Candidate forearm surgery ASA class I and II
Exclusion criteria:
Rinod's disease Sickle cell anemia History of allergy to the drugs used in the study Affected limb cyanosis Drugs and psychotropic use There is more than one body fracture or surgery Pregnancy Chronic pain syndrome Neurological disorders in the hand Hypertension-related disease and heart erythema and heart failure
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in two 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 double blind. Researcher who complete questionnaire and analyzer and participant 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 and C 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
2019-07-21, 1398/04/30
Ethics committee reference number
IR.ARAKMU.REC.1398.112

Health conditions studied

1

Description of health condition studied
forearm surgery
ICD-10 code
S52.9
ICD-10 code description
Unspecified fracture of forearm

Primary outcomes

1

Description
Duration of motor block
Timepoint
Every 5 minute
Method of measurement
Minute

2

Description
Duration of Sensory block
Timepoint
Every 1 minute
Method of measurement
Minute

3

Description
Pain
Timepoint
After filling the tourniquet, at the time of 15, 30 and 45 and every 15 minutes until the end of surgery
Method of measurement
Visual Analogue Scale Questionnaire

4

Description
Mean use of narcotic
Timepoint
24 hour after surgery
Method of measurement
Milligram

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: We will inject 0/5 micro gram in kilogram co.Dexmedetomidine (Exir Co.Iran) plus 35 milliliter Rupivacaine 0/2%(Molteni Co.Italia).
Category
Treatment - Drugs

2

Description
Intervention group: we will inject 2 milligram Granisetron(Caspian Co.Iran) plus 35 milliliter Rupivacaine 0/2%(Molteni Co.Italia).
Category
Treatment - Drugs

3

Description
Intervention group: We will inject 200 micro gram Nitroglycerin (Caspian Co.Iran) plus 35 milliliter Rupivacaine 0/2%(Molteni Co.Italia)
Category
Treatment - Drugs

4

Description
Control group: we will inject 5 milliliter normal saline plus 35 milliliter Rupivacaine 0/2%(Molteni Co.Italia)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Esmaeel Moshiri
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
moshiri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
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
alikamaliir@yahoo.com
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 Hesamedin Modir
Position
Associate 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
Email
modir.he@gmail.com

Person responsible for scientific 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
Shahid Shirodi street, Valiasr square, Valiasr hospital
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
moshiri@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Morteza Molok
Position
Resident of anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Payambar Azam Complex, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
molok@yahoo.com
Web page address

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
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Moshiri
What processes are involved for a request to access data/document
They have to write letters to the professors and the university
Comments
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