Protocol summary

Study aim
General goal: to compare the effectiveness of injection of lidocaine anesthesia with articaine on heart rate, blood oxygen saturation percentage and blood pressure in patients who are candidates for tooth extraction. functional goal: If the superiority of each is determined, it can be a good guide for dentists to choose an anesthetic agent.
Design
Clinical trial, double blind, phase 4 on 44 people, two parallel groups A block allocation table will be used for randomization
Settings and conduct
This study will be conducted on patients referred to Gorgan Dental Faculty. First, the patient rests upright for 5 minutes, and to evaluate the dental anxiety of the patients, the questionnaire of Stuttered et al. If the patient's dental anxiety is in the normal range (less than equal to 90), then the patient's heart rate (HR) and blood oxygen saturation (SPO2) were measured by a fingertip pulse oximeter before anesthesia injection. On the index finger of the patient's right hand, the blood pressure is also measured by a digital sphygmomanometer. Then the anesthetic injection is performed by the research associate student. And then the HR and SPO2 values ​​are measured by the pulse oximeter on the same index finger. The blood pressure measurement will be done in the same way.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1) Healthy people between 30 and 50 years old 2) Candidates for extraction of lower jaw teeth Non-entry criteria: 1) People with cardiovascular, renal, respiratory disease, liver failure and hyperthyroidism 2) Pregnant women 3) All diabetic patients 4) People with dental anxiety outside the normal range 5) People who take drugs affecting heart rate
Intervention groups
In this study, we have 2 groups, one of which is injected with anesthetic lidocaine and the other with articaine.
Main outcome variables
heart beat Blood oxygen saturation blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240703062318N1
Registration date: 2024-08-22, 1403/06/01
Registration timing: prospective

Last update: 2024-08-22, 1403/06/01
Update count: 0
Registration date
2024-08-22, 1403/06/01
Registrant information
Name
Seyed Alireza Fazeli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3224 1889
Email address
alirezafazeli15@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anesthetic injection lidocaine with articaine on changes in heart rate ,blood oxygen saturation percentage and blood pressure in Candidate patients for tooth extraction: a Randomized clinical trial
Public title
Investigating the effectiveness of injection of lidocaine and articaine anesthesia on heart rate, blood oxygen saturation percentage and blood pressure
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy people between 30 and 50 years old Candidates for extraction of lower jaw teeth
Exclusion criteria:
People with cardiovascular, renal, respiratory disease, liver failure and hyperthyroidism pregnant women All diabetic patients People with dental anxiety outside the normal range People who take medications that affect heart rate
Age
From 30 years old to 50 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Block allocation method: People are randomly assigned to articaine (A) and lidocaine (B) groups. Random block method will be used to assign people to groups. For this purpose, all six positions of letters A and B are considered in blocks of four as in the table below. AABB (1) ABAB (3) ABBA (5) BBAA (2) BABA(4) BAAB(6). 11 blocks of 4 are needed to allocate 22 samples in each group (44 people in total). To select 11 blocks first,11 random numbers between 1 and 6 will be generated by repetition (with placement). In this way, a sequence of letters A and B including 44 letters (22 letters A and 22 letters B) will be created.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind clinical trial study, all injections will be performed by a trained student (researcher) under the supervision of a maxillofacial surgeon (clinician), and the student will be aware of what kind of anesthetic to use for each patient will inject the anesthetic in opaque syringes to the patients and the patient will not know the type of anesthetic injected. Also, the person (nurse) who will measure the desired values ​​(HR, SPO2 and BP) before and after the injection will not know what kind of anesthetic the patient has received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Hirkan boulevard , Central Organization of Golestan University of Medical Sciences and Healthcare Services
City
Gorgan
Province
Golestan
Postal code
4918936316
Approval date
2024-08-13, 1403/05/23
Ethics committee reference number
IR.GOUMS.REC.1403.181

Health conditions studied

1

Description of health condition studied
Blood pressure
ICD-10 code
ICD-10 code description

2

Description of health condition studied
heartbeat
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Blood oxygen saturation percentage
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Number of heartbeats
Timepoint
Before and after injection of anesthesia
Method of measurement
by pulse-oximetry

2

Description
Blood oxygen saturation
Timepoint
Before and after injection of anesthesia
Method of measurement
by pulse-oximetry

3

Description
Blood pressure
Timepoint
Before and after injection of anesthesia
Method of measurement
Digital pressure gauge device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients receiving persocaine-E which contains lidocaine 2% with epinephrine 1/80000 from Darupakhsh company. Each patient will be injected only once and a carpool containing 1.8 ml of the anesthetic substance in one minute by inferior alveolar nerve block method.
Category
Treatment - Other

2

Description
Intervention group: Patients receiving Dentacaine 200 which contains articaine 4% with epinephrine 1/200000 from Exir pharmaceutical company. Each patient will be injected only once and one carpool containing 1.8 ml of anesthetic substance in one minute by inferior alveolar nerve block method. .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Dentistry, Golestan University of Medical Sciences
Full name of responsible person
Seyed Alireza Fazeli
Street address
Factuly of Dentistry,5th shahriar,Shahriar Town
City
Gorgan
Province
Golestan
Postal code
4913983632
Phone
+98 17 3262 7824
Email
dentlibrary@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Rashid Soufizadeh
Street address
Factuly of Dentistry,5th Shahriar,Shahriar Town
City
Gorgan
Province
Golestan
Postal code
4913983635
Phone
+98 17 3262 7871
Email
Rashidsoufizadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyed Alireza Fazeli
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Pardisan dorm complex,17th Daneshjoo Ave,Jahad Town
City
Gorgan
Province
Golestan
Postal code
4914735780
Phone
+98 17 3224 1889
Email
alirezafazelli15@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Rashid Soufizadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Factuly of Dentistry,5th Shahriar,Shahriar Town
City
Gorgan
Province
Golestan
Postal code
4913983632
Phone
+98 17 3262 7823
Email
rashidsoufizadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Seyed Alireza Fazeli
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Pardisan dorm complex,17th Daneshjoo Ave,Jahad Town
City
Gorgan
Province
Golestan
Postal code
4914735780
Phone
+98 17 3224 1889
Fax
Email
alirezafazeli15@gmail.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After de-identifying individuals, the following information is shared: age gender Blood pressure before and after the injection of each anesthetic drug Blood oxygen saturation percentage before and after injection of each anesthetic drug The heart rate before and after the injection of each of the anesthetic drugs
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Only for researchers working in academic and scientific institutions and students of medical sciences, including medicine, dentistry, pharmacy, etc.
Under which criteria data/document could be used
As a study resource for clinical science research
From where data/document is obtainable
By email to the responsible author of the article resulting from the study Mr. Seyed Alireza Fazeli Alirezafazeli15@gmail.com
What processes are involved for a request to access data/document
If the request is from colleagues and people working in the clinical fields of medical sciences, there will be no process.
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