Comparison of effect of three local anesthesia including lidocaine 2% epinephrine 1/80000, prilocaine 3% flypressin 0/03%, plain mepivacaine 3% on blood pressure in hypertensive patients before tooth extraction
Recommendation for use of epinephrine in dental local anesthesia is not for agreement in hypertensive patients. However several study allow its use with regard to maximum doses.
In this study, patients that referred for mandibular tooth extraction and are hypertensive known case and their pre injection blood pressure is lower than 159/94 mmHg, are selected. They are randomly divided to three groups with 20 members. Group 1 persocaine solution (lidocaine 2% epinephrine 1/80000- darou pakhsh, Iran), group 2 dentanest (prilocaine 3% felypressin 0/03 IU- darou pakhsh , Iran) and group3 scandinibsa(plain mepivacaine3%- inibsa, Spania). Solution volume is determined two cateridges (3/6 ml) (maximum dose for epinephrine equally with 0/04 mgr). blood pressure is recorded in three time with pulse oximetry. Time 1 (before injection) that is 5 minute after sit down and resting on dental unit. Immediately after injection (time 2) and 5 minutes later (time 3) blood pressure is recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061013621N1
Registration date:2013-06-23, 1392/04/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-23, 1392/04/02
Registrant information
Name
Seyed Hamed Jalalian Hashemi
Name of organization / entity
Zahedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 54 1241 4004
Email address
hamedjh59@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology Assistance of Zahedan University of Medical Science
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of three local anesthesia including lidocaine 2% epinephrine 1/80000, prilocaine 3% flypressin 0/03%, plain mepivacaine 3% on blood pressure in hypertensive patients before tooth extraction
Public title
Effects of different anesthetic agents in patients with controlled hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients who need inferior alveolar nerve block injection to extraction teeth; patients with high blood pressure but under control and below 94/159 mmHg.
Exclusion criteria: cardiovascular disease: unstable angina, myocardial infarction before 6 months, 6 months following cerebrovascular accident, CABG under 6 months, uncontrolled cardiac arrhythmias, decompensated congestive heart disease; untreated hyperthyroid, uncontrolled diabetes mellitus; sulfate-sensitive asthma, real allergies to sulfites; pregnant and lactating women.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Science
Street address
University of Medical Science, Dr Hesabi square
City
Zahedan
Postal code
9817699693
Approval date
2013-06-21, 1392/03/31
Ethics committee reference number
92-2092
Health conditions studied
1
Description of health condition studied
Blood pressure of patients
ICD-10 code
Z01.3
ICD-10 code description
Examination of blood pressure
Primary outcomes
1
Description
Blood pressure
Timepoint
3 times: 5 min before injection, immediately after injection and 5 min after injection
Method of measurement
Blood pressure is measured in millimeters of mercury with a pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Two anesthetic cartridges containing lidocaine 2% epinephrine 1/80000
Category
Treatment - Drugs
2
Description
Two anesthetic cartridges containing prilocaine 3% flypressin 0/03%
Category
Treatment - Drugs
3
Description
Two anesthetic cartridges containing mepivacaine 3%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of surgery - Zahedan Dental School
Full name of responsible person
Shamsoodin Rigi
Street address
Dental School, Azadegan Street
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Assistance of Zahedan University of Medical Science
Full name of responsible person
Dr Hamid Reza Mahmood Zade Sagheb
Street address
University of Medical Science, Dr Hesabi square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Assistance of Zahedan University of Medical Science
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
Zahedan University of Medical Science
Full name of responsible person
Shamsoodin Rigi
Position
Dental student
Other areas of specialty/work
Street address
Dental School, Azadegan street
City
Zahedan
Postal code
9817699693
Phone
+98 54 1244 1814
Fax
Email
shams554@ymail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Dr Seyed Hamed Jalalian
Position
Specialist in Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Dental School, Azadegan street
City
Zahedan
Postal code
9817699693
Phone
+98 54 1244 1814
Fax
+98 54 1241 4003
Email
hamedjh59@yahoo.co.in
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Dr Seyed Hamed Jalalian
Position
Specialist in Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Dental School, Azadegan street
City
Zahedan
Postal code
9817699693
Phone
+98 54 1244 1814
Fax
Email
hamedjh59@yahoo.co.in
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)