This case-control randomized clinical trial without blinding aims to determine the effect of epinephrine containing lidocaine on blood pressure and heart rate of 18 to 45 years old patients referring for surgery for the permanent teeth. In case of cardiovascular disease, asthma, hyperthyroidism, receiving antihypertensive, antidepressants and anti-anxiety drugs and sensitivity to lidocaine, patients are excluded. One hundred patients requiring dental procedures are divided randomly into two groups of intervention and control. Inferior alveolar nerve block is performed by injection cartridges and 15 minutes after the injection and then lip anesthesia, access cavity is prepared. For the intervention group 1.8 mL cartridges containing 20 mg lidocaine hydrochloride 2% with 12.5 micrograms epinephrine 1/80000 with brand name of persocaine made by Daroopakhsh Manufacturing Co. will be injected. For patients in the control group, the same volume of lidocaine hydrochloride 2% (100 mg per 5 ml) made by daroopakhsh Co. will be injected and number of cartridges are recorded. Patients sit on dental unit in the semi-supine position and after 20 minutes rest, the patient's left arm is parallel to the surface of the heart. In 3 times (before and 15 minutes after the injection of local anesthesia and 10 minutes after the end of surgery) blood pressure and heart rate are measured and recorded and the results are compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040533235N1
Registration date:2017-07-15, 1396/04/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-15, 1396/04/24
Registrant information
Name
Amirhossein Pakravan
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
apakravan@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of evaluation of blood pressure and heart rate by injecting epinephrine containing and without epinephrone local anesthetia
Public title
Evaluation of blood pressure and heart rate by injecting epinephrine containing local anesthetia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 45 years; refering for removal of permanent teeth.
Exclusion criteria: cardiovascular disease; asthma; hyperthyroidism; receiving antihypertensive, antidepressants and anti-anxiety drugs; sensitivity to lidocaine
Age
From 17 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using table of random numbers, patients are randomly divided into two groups, age and gender-matched
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Moallem square, Sari, Iran
City
Sari
Postal code
Approval date
2017-03-15, 1395/12/25
Ethics committee reference number
IR.MAZUMS.REC.95.2338
Health conditions studied
1
Description of health condition studied
Blood pressure
ICD-10 code
Z01.3
ICD-10 code description
Examination of blood pressure
2
Description of health condition studied
Heart beat
ICD-10 code
R00.8
ICD-10 code description
Abnormalities of heart beat
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
Before injection of anesthetic, 15 minutes after the injection of local anesthesia and 10 minutes after the end of surgery
Method of measurement
mmHg
2
Description
Diastolic blood pressure
Timepoint
Before injection of anesthetic, 15 minutes after the injection of local anesthesia and 10 minutes after the end of surgery
Method of measurement
mmHg
3
Description
Heart rate
Timepoint
Before injection of anesthetic, 15 minutes after the injection of local anesthesia and 10 minutes after the end of surgery
Method of measurement
Number per minute
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group 1.8 mL cartridges containing 20 mg lidocaine hydrochloride 2% with 12.5 micrograms epinephrine 1/80000 with brand name of persocaine made by Daroopakhsh Manufacturing Co. will be injected.
Category
Prevention
2
Description
For patients in the control group, the same volume of lidocaine hydrochloride 2% (100 mg per 5 ml) made by daroopakhsh Co. will be injected
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry of Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein Pakravan
Street address
Faculty of Dentistry, Near Tooba Clinic, Khazar bou;evard, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein Pakravan
Street address
Dentistry faculty, Near Tooba clinic, Sari, Iran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein Pakravan
Position
Assistant Professor
Other areas of specialty/work
Street address
Dentistry faculty, Near Tooba clinic, Sari, Iran
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
apakravan@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Amirhossein Pakravan
Position
Assistant proffessor
Other areas of specialty/work
Street address
Dentistry faculty, Near Tooba clinic, Sari, Iran
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
apakravan@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shahryar Karami
Position
Student
Other areas of specialty/work
Street address
Dentistry faculty, Near Tooba clinic, Sari, Iran
City
Sari
Postal code
Phone
+98 11 3334 2334
Fax
Email
shahryar.karami41171@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)