determining of efficacy of intravenous and intratechal Dexmedetomidine on perioperative shivering after spinal anesthesia
Design
this study is a double blinded randomized clinical trial which applies to 150 patients that were selected with block randomization method in three groups.
Settings and conduct
This study is conducted in the Kashan Shahid Beheshti Hospital.The patient and nurse assessor will be unaware from type of study group.
In the intravenous Dexmedetomidine group, spinal anesthesia is performed with bupivacaine and sodium chloride 0.9% as placebo and intravenous Dexmedetomidine is infused.
In the intrathecal Dexmedetomidine group,spinal anesthesia is performed with bupivacaine and Dexmedetomidine and sodium chloride 0.9% is infused as a placebo.
In the control group, spinal anesthesia is performed with bupivacaine and sodium chloride 0.9% as placebo and sodium chloride 0.9% is infused as a placebo.
Participants/Inclusion and exclusion criteria
Patients aged 18-70 years from both sexes who are candidates for surgery in the lower abdomen or lower extremities undergo spinal anesthesia enter the study.Patients with core body temperature above 37.5 °C,pregnancy,history of allergy to the drugs used in the study,presence of contraindication of spinal anesthesia,uncontrolled thyroid disease,Parkinson's disease,unstable coronary artery disease,grade II and III cardiac blockage, severe mitral valve stenosis and surgeries requiring excessive washing with fluids (eg TURP) do not enter to study.
Intervention groups
Patients are divided in three groups:The intrathecal Dexmedetomidine group which is injected intrathecal and intravenous Dexmedetomidine group which is given intravenously and control group which is given intravenous and intrathecal placebo.
Comparison of efficacy of intravenous and intratechal dexmedetomidine on perioperative shivering after spinal anesthesia
Public title
effect of intravenous and intratechal dexmedetomidine on shivering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-70 years/old
ASA class I-II
lower abdominal and lower limb surgery
spinal anesthesia for surgery
Duration of surgery is 30-120 minutes.
Exclusion criteria:
Core body temperature higher than 37.5 ° C
Pregnancy
History of allergy to the drugs used in the study
Contraindications for spinal anesthesia
Patient with uncontrolled thyroid disease
Parkinson's Disease
disautonomy
Raynaud syndrome
Cardiopulmonary Disease
History of alcohol consumption
unstable coronary artery disease
heart block (degree of II and III)
congestive heart failure
severe mitral stenosis
vasodilator drugs consumption
Surgeries requiring washing with excess fluid (eg TURP).
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
in randomized blocking using 6 blocks are divided into three groups of intravenous dexmedetomidine, intrathecal and placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
After explaining the entry into the study for patients and obtaining written consent from them and implementing the randomization method,Based on designated group, researcher or the person substituting the drug or placebo is prescribed, as in the intrathecal dexmedetomidine, IV normal saline is prescribes and in the group IV Dexmedetomidine, intrathecal normal saline is prescribes, and in the control group prescribes IV and intrathecal normal saline, Without the assessor being informed of the type of prescribing and patient group, and the unaware assessor who are anesthetist nurses in the operating and recovery room, record the variables of the study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kashan University of Medical Sciences
Street address
Hekmat 56 Ave., Ghotb Ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2016-08-28, 1395/06/07
Ethics committee reference number
IR.KAUMS.REC.1395.56
Health conditions studied
1
Description of health condition studied
shivering after spinal anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
shivering
Timepoint
During surgery every 5 minutes and during recovery every 15 minutes
Method of measurement
shivering Usta and Gozdemir scale
Secondary outcomes
1
Description
core temperature
Timepoint
Every 15 minutes from the start of surgery to the end of recovery
Method of measurement
digital tympanic thermometer
2
Description
heart rate
Timepoint
The first 15 minutes of starting surgery every 5 minutes and then until the end of recovery every 15 minutes
Method of measurement
Digital Cardiac Monitoring
3
Description
systolic blood pressure
Timepoint
The first 15 minutes of starting surgery every 5 minutes and then until the end of recovery every 15 minutes
Method of measurement
Digital Cardiac Monitoring
4
Description
diastolic blood pressure
Timepoint
The first 15 minutes of starting surgery every 5 minutes and then until the end of recovery every 15 minutes
Method of measurement
Digital Cardiac Monitoring
Intervention groups
1
Description
Intervention group: intrathecal Dexmedetomidine group spinal anesthesia with 3ml (15mg) hyperbaric bupivacaine 0.5% (Marcaine spinal 0.5% AstraZeneca) + 0.5ml Dexmedetomidine (Precedex 100µg/ml) from its diluted solution as 10µg/ml (5µg) and infused intravenous NaCl 0.9% first 1ml/kg/10min and then 0.5ml/kg/hour.
Category
Treatment - Drugs
2
Description
Intervention group: intravenous Dexmedetomidine group spinal anesthesia with 3ml (15mg) hyperbaric bupivacaine 0.5% (Marcaine spinal 0.5% AstraZeneca) + 0.5ml NaCl 0.9% and infused intravenous Dexmedetomidine (Precedex 100µg/ml) from its diluted solution as 1µg/ml first 1ml/kg/10min and then 0.5ml/kg/hour.
Category
Treatment - Drugs
3
Description
Control group: spinal anesthesia with 3ml (15mg) hyperbaric bupivacaine 0.5% (Marcaine spinal 0.5% AstraZeneca) + 0.5ml NaCl 0.9% and infused intravenous NaCl 0.9% first 1ml/kg/10min and then 0.5ml/kg/hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Hamed Pahlevani
Street address
Hekmat 56 ave., Ghotb Ravandi blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
pahlavani-h@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafsheh
Street address
Hekmat 56 ave., Ghotb Ravandi blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5557 5057
Email
banafsheh_h@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Hamed Pahlevani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hekmat56 ave., Ghotb Ravandi blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
pahlavani-h@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamed Pahlevani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hekmat 56 ave., Ghotb Ravandi blvd.
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
pahlavani-h@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamed Pahlevani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hekmat 56 ave., Ghotb Ravandi blvd.
City
Kashan
Province
Isfehan
Postal code
87115981151
Phone
+98 31 5554 0021
Email
pahlavani-h@kaums.ac.ir
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
Not applicable
Title and more details about the data/document
data can be shared after unidentifiable people.
When the data will become available and for how long
Start the access period after printing the results.
To whom data/document is available
Researchers working in academic, scientific and industrial institutions.
Under which criteria data/document could be used
Does not apply.
From where data/document is obtainable
Dr. Hamed Pahlevani- kashan- shahid beheshti hospital-Postal code: 8715981151
pahlavani-h@kaums.ac.ir
What processes are involved for a request to access data/document
After sending the request by email or post, Immediately he is contacted and After knowing the cause and purpose of data access, They will be sent immediately via e-mail (or any other method).