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Comparison effect of subcutaneous Dexmedetomidine and subcutaneous Marcaine 0.5 % in hemodynamic changes and sedation during hernia surgery and management of pain after surgery

Protocol summary

Study aim
Aim of this study is evaluation effect of subcutaneous Dexmedetomidine and subcutaneous Marcaine 0.5 % in hemodynamic change and sedation during hernia surgery and management of pain after surgery.
Design
This study is clinical trial and double blind.120 patients candidate hernia surgery in valiasr hospital were divided in 3 groups by simple randomization.Groups are parallel.
Settings and conduct
120 patients candidate hernia surgery in valiasr hospital.This study is 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.We record mean arterial blood pressure,heart rate , oxygen saturation, pain in each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 years old to 65 years old ,ASA Class I and II ,candidates for hernia surgery ,body mass index less than 30 ,no allergy to used drugs ,lack of underlying illness, no smoking and addiction; Exclusion criteria: Dissatisfaction with participating in the study,refusal to undergo intracutaneous injection
Intervention groups
In the first group,we inject 5 milligram Marcaine 0.5% (Aboreihan Co)and 1 micro gram in kilogram Dexmedetomidin(PFIZER [America])and distilled water.Final volume is 10 milliliter. In the second group, we inject 5 milligram Marcaine 0.5%(Aboreihan Co) and distilled water.Final volume is 10 milliliter. We inject 10 milliliter normal saline(Samen Co) in placebo group.
Main outcome variables
Mean arterial blood pressure,heart rate , oxygen saturation percentage, pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N99
Registration date: 2019-03-20, 1397/12/29
Registration timing: registered_while_recruiting

Last update: 2019-03-20, 1397/12/29
Update count: 0
Registration date
2019-03-20, 1397/12/29
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
2018-08-23, 1397/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of subcutaneous Dexmedetomidine and subcutaneous Marcaine 0.5 % in hemodynamic changes and sedation during hernia surgery and management of pain after surgery
Public title
Comparison effect of subcutaneous Dexmedetomidine and subcutaneous Marcaine 0.5 % in hemodynamic changes and sedation during hernia surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years old to 65 years old ASA Class I and II Candidates for hernia surgery Body mass index less than 30 No allergy to used drugs Lack of underlying illness No smoking and addiction
Exclusion criteria:
Dissatisfaction with participating in the study Refusal to undergo intra cutaneous injection
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number table in division of groups in two groups A and B. Randomization method: Simple randomization. Random unit: Individual. How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group. Allocation concealment:Numbered drug containers
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 and C are available to analyzer and outcome assessor.The syringe containing the drugs are covered and labeled as A and B and C at the discretion of anesthesiology residents.
Placebo
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
2018-08-19, 1397/05/28
Ethics committee reference number
IR.ARAKMU.REC.1397.131

Health conditions studied

1

Description of health condition studied
Hernia surgery
ICD-10 code
K40
ICD-10 code description
Inguinal hernia

Primary outcomes

1

Description
Mean arterial blood pressure
Timepoint
Every 5 minutes to the end of surgery and recovery
Method of measurement
Barometer

2

Description
Heart rate
Timepoint
Every 5 minutes to the end of surgery and recovery
Method of measurement
Beat in minute

3

Description
Oxygen saturation
Timepoint
Every 5 minutes to the end of surgery and recovery
Method of measurement
Oximeter

4

Description
Pain
Timepoint
At recovery and at 2, 4, 6, 12, and 24 hours after surgery
Method of measurement
Questionnaire visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: We inject 5 milligram Marcaine 0.5% (Aboreihan Co) and 1 micro gram in kilogram Dexmedetomidin(PFIZER [America]) and distilled water.Final volume is 10 milliliter.
Category
Treatment - Drugs

2

Description
Intervention group 2: We inject 5 milligram Marcaine 0.5%(Aboreihan Co) and distilled water.Final volume is 10 milliliter.
Category
Treatment - Drugs

3

Description
Control group: We inject 10 milliliter normal saline(Samen Co) in placebo group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr Shirin Pazoki
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
pazuki@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Vice Chancellor For Research, Arak University Of Medical Science
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
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 Hesamedin Modir
Position
Assistante 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 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 updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mahdi Maktobian
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
maktobian@arakmu.ac.ir
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 Shirin Pazuki
What processes are involved for a request to access data/document
They have to write letters to the professors and the university
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