In this study, 60 patients undergoing elective lower limb surgery were divided into two groups. In the first group, spinal anesthesia was performed through L4-L5, L3-L4 with bupivacaine and in the intervention group, epidural anesthetic from L3-L4 or L4-L5 space with Bupivacaine . After surgery, the QT interval is evaluated in the patient's electrocardiogram.
Settings and conduct
Clinical trial; Kashani Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: the QTc interval is less than 440 milliseconds in the pre-operative electrocardiogram
Exclusion criteria:treated with antiarrhythmic drugs; are treated with QTc interval augmenting drugs; history of cardiac disease; electrolyte imbalance
Intervention groups
In the first group, spinal anesthesia are performed through L4-L5, L3-L4 with bupivacaine and in the intervention group epidural anesthesia from L3-L4 or L4-L5 space with bupivacaine.
Main outcome variables
QT spacing of the electrocardiogram
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190120042427N1
Registration date:2019-02-14, 1397/11/25
Registration timing:prospective
Last update:2019-02-14, 1397/11/25
Update count:0
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Amin Panahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
aminpanahi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of epidural and spinal anesthesia on ventricular repolarization in patients undergoing elective lower limb surgery
Public title
Comparative study of epidural vs. spinal anesthesia on ventricular repolarization in patients undergoing lower limb surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The QTc interval is less than 440 milliseconds in the pre-operative electrocardiogram
Exclusion criteria:
Treated with antiarrhythmic drugs
Are treated with QTc interval augmenting drugs
History of cardiac disease
Electrolyte imbalance
Age
From 60 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified Random Sampling،Randomization was performed using software and permutable blocks, in which the blocks were 4 and the number was respectively the lowest and the highest in the fourth and first group, and then the third and the second group respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient is not aware of the kind of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice Chancellor of Research and Technology , Shahrekord University of Medical Sciences, Kashani Blvd, Shahrekord,Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718788
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.SKUMS.REC.1395.41
Health conditions studied
1
Description of health condition studied
surgery operation
ICD-10 code
Y60.0
ICD-10 code description
During surgical operation
Primary outcomes
1
Description
QT spacing of the electrocardiogram
Timepoint
after surgery
Method of measurement
electrocardiogram
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: epidural anesthesia done from L3-L4 or L4-L5 space with bupivacaine injection.
Category
Prevention
2
Description
Control group: In the first group, spinal anesthesia was performed through L4-L5, L3-L4 with bupivacaine.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Mahmoud Akhlaghi
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718796
Phone
+98 38 3222 0016
Email
akhlaghi23@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Kamal Solati
Street address
Vice Chancellor of Research and Technology Shahrekord University of Medical Sciences, Kashani Blvd, Shahrekord,Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
solati@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Mahmoud Akhlaghi
Position
Anesthesiology
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718796
Phone
+98 38 3222 0016
Email
akhlaghi23@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mahmoud Akhlaghi
Position
Assocoate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718796
Phone
+98 38 3222 0016
Email
akhlaghi23@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mahmoud Akhlaghi
Position
Assocoate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, ParastarAvenue,Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718796
Phone
+98 38 3222 0016
Email
akhlaghi23@yahoo.com
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
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
Title and more details about the data/document
Patient file information
When the data will become available and for how long
six month
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
article
From where data/document is obtainable
journal
What processes are involved for a request to access data/document