Comparison of the begning of anesthesia induced by two methods of using lidocaine in intravenous regional anesthesia of the upper limb
Design
Clinical trial of a single-blind, control group with a sample size of 40 people
Settings and conduct
Meanwhile to explaining the intervention and Taking consent from the patient, amount of 20-15 ml of lidocaine 1% is injected Intravenous method with respect to the maximum dose of 3 mg per kilogramt, and the results will be checked.
Participants/Inclusion and exclusion criteria
1- Patients undergoing upper limb (hand and forearm) surgery less than 90 minutes
2. Patients are classified in the American Association of Anesthesiologists in Classes 1 and 2
3- Age of patients between 18 and 60 years
4. Patients who do not have the tendon to close the tourniquet in the limbs (sickle cell disease, rhinitis, history of lidocaine allergy, history of favism, seizure)
Non-arrival conditions:
1. Failure to get the venous line in the corresponding limb
2- Drain the tourniquet after injection of the drug for any reason
3- The length of the surgery is more than 90 minutes
Intervention groups
Use of 20-15 ml of lidocaine 1% based on the maximum dose of 3 mg kg of anesthetized upper limb pation
Main outcome variables
Anesthesia time and systolic and diastolic blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181124041740N1
Registration date:2020-04-14, 1399/01/26
Registration timing:retrospective
Last update:2020-04-14, 1399/01/26
Update count:0
Registration date
2020-04-14, 1399/01/26
Registrant information
Name
Alireza Talai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5725 1002
Email address
talaee.a@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the begning of anesthesia induced by two methods of using lidocaine in intravenous regional anesthesia of the upper limb
Public title
Comparison of the begning of anesthesia induced by two methods of using lidocaine in intravenous regional anesthesia of the upper limb
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing upper limb (hand and forearm) surgery should be under 90 minutes
Patients are classified in the American Association of Anesthesiologists in Classes 1 and 2
The age of the patients is between 18 and 60 years
Patients who do not have the ability to close the tourniquet in the limbs (sickle cell disease, rhinitis, history of lidocaine allergy, history, favism, seizure)
Exclusion criteria:
Failure to get the venous line in the relevant limb
Drain the tourniquet after injection of the drug for any reason
The length of the surgery is longer than 90 minutes
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants were described as having anesthesia but were unaware of the amount and concentration of the drug
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical sciences , Dr Mehdizade street , Pardise
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2015-10-14, 1394/07/22
Ethics committee reference number
IR.GMU.REL.1394.42
Health conditions studied
1
Description of health condition studied
Evaluation of the time to reach complete upper limb anesthesia with intravenous anesthesia
ICD-10 code
ICD-10 code description
موضوع مورد مطالعه بیماری نیست
Primary outcomes
1
Description
DurationTime to start numbness
Timepoint
every minute immediately after intravenous administration of lidocaine
Method of measurement
Pinprick
Secondary outcomes
1
Description
blood pressure
Timepoint
before icision and immediately after incision
Method of measurement
Mercury pressure gauge
Intervention groups
1
Description
Intervention group: In the first group, 40 ml lidocaine half a percent was injected intravenous
Category
Treatment - Drugs
2
Description
Intervention group: In the second group, 20 ml lidocaine one percent was injected intravenous
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
15 khordad hospital
Full name of responsible person
Alireza Talai
Street address
Gonabad University of Medical sciences , Dr Mehdizade street , Pardise
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5723 6833
Email
talaee.a@gmu.ac.ir
Web page address
http://gmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Alireza Talai
Street address
Gonabad University of Medical sciences , Dr Mehdizade street , Pardise
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5723 6833
Email
talaee.a@gmu.ac.ir
Web page address
http://gmu.ac.ir/
Grant name
0
Grant code / Reference number
0
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Gonabad University of Medical
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
Gonabad University of Medical Sciences
Full name of responsible person
Alireza Talai
Position
MSC
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical sciences , Dr Mehdizade street , Pardise
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5723 6833
Email
talaee.a@gmu.ac.ir
Web page address
http://gmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Alireza Talai
Position
MSC
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical sciences , Dr Mehdizade street , Pardise
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5723 6833
Email
talaee.a@gmu.ac.ir
Web page address
http://gmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Alireza Talai
Position
MSC
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad University of Medical sciences , Dr Mehdizade street , Pardise
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5723 6833
Email
talaee.a@gmu.ac.ir
Web page address
http://gmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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
No - There is not 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