Clinical trial of comparison of heart rate and blood pressure changes due to administration of anesthesia agent with and without vasoconstrictor in healthy subjects.
Objectives: The aim of this study is the comparison of heart rate and blood pressure changes due to administration of local anesthetic agent with and without vasoconstrictor.
Design: Randomized clinical trial.
Setting and Conduct: We study 182 patients referring for extraction of Mandibular Molar teeth in dentistry clinic of Tabriz faculty of dentistry in the form of two equal groups. Patients will randomly be assigned into one of two groups. We use Lidocaine2%+1:80000 Epinephrine cartridge for one group and Mepivacaine 3% cartridge for the other group.
Participants including major eligibility criteria: Patients referring for Mandibular teeth extraction at the age range of 25 to 50 years will enroll into the study. Patients with chronic usage of any drugs, history of any systemic disease and any allergy for Lidocaine, Mepivacaine and Adrenaline will be excluded.
Intervention: After randomly assigning into two groups we use Lidocaine2%+1:80000 Epinephrine cartridge for one group and Mepivacaine 3% cartridge for the other group.
Main outcome measures (variables): Systolic and Diastolic blood pressure and heart rate before and 15 minutes after tooth extraction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011510935N2
Registration date:2013-03-09, 1391/12/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-09, 1391/12/19
Registrant information
Name
Mohammad Ali Ghavimi
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 6147
Email address
ghmd@irimc.org
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-09-21, 1391/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of heart rate and blood pressure changes due to administration of anesthesia agent with and without vasoconstrictor in healthy subjects.
Public title
Comparison of heart rate and blood pressure changes due to administration of local anesthetic agent with and without Vasoconstrictor.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: 1-Being at the age between 25-50 years; 2-Indication for Mandibular Molar teeth extraction.
Exclusion criteria: 1-History of any systematic disease; 2-History of chronic usage of any drug in the past 6 months; 3-Any allergy to Lidocaine, Mepivacaine and Adrenaline.
Age
From 25 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
182
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of medical sciences and health services
Street address
Central office of Tabriz university of medical sciences, Golgasht street, Azadi street.
City
Tabriz
Postal code
5165687386
Approval date
2013-01-24, 1391/11/05
Ethics committee reference number
91188
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Pulse rate
Timepoint
15 minutes before intervention, 15 minutes after intervention
Method of measurement
Pulse rate per minute- Pulse oxymeter
2
Description
Blood Pressure
Timepoint
15 minutes before intervention, 15 minutes after intervention