Assessing hemodynamic changes (heart rate, blood pressure and oxygen saturation) comparing mepivacaine Hcl 3% with perilocaine 3%+ felypressin in controlled hypertensive patients after infra-alveolar block.
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 2 on 32 patients. Excel software rand function was used for randomization.
Settings and conduct
Patients referred to the surgical ward of Shiraz Dental School are selected at random. The drugs are coded as A and B without the researcher's awareness and randomly selected by the researcher.
Participants/Inclusion and exclusion criteria
Patients with hypertension who are controlled with antihypertensive drugs.
Intervention groups
Patients with hypertension are divided into two groups and as anesthesia drugs that have the least cardiovascular changes are used as anesthesia.
Main outcome variables
Changes in pulse, blood pressure, blood oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200707048045N1
Registration date:2020-09-03, 1399/06/13
Registration timing:retrospective
Last update:2020-09-03, 1399/06/13
Update count:0
Registration date
2020-09-03, 1399/06/13
Registrant information
Name
Ahmad Homayoun
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3228 4031
Email address
ahmad.homayoun9@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-22, 1399/04/02
Expected recruitment end date
2020-08-15, 1399/05/25
Actual recruitment start date
2020-06-22, 1399/04/02
Actual recruitment end date
2020-07-26, 1399/05/05
Trial completion date
2020-07-31, 1399/05/10
Scientific title
Hemodynamic changes (heart rate, blood pressure and oxygen saturation) comparing mepivacaine Hcl 3% with perilocaine 3%+ felypressin in controlled hypertensive patients after infra-alveolar block.
Public title
Vital sign changes in use of prilocaine and mepivacaine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with controlled hypertension who are willing to cooperate
Exclusion criteria:
Patients with a history of drug allergy, a history of asthma, nasal polyps, bronchospasm or angioedema,
heart failure or liver failure,
pregnancy,
patients with idiopathic or congenital methemoglobinemia,
patients with bleeding disorders,
patients taking anticoagulant drugs
failure to sign a written consent
Age
From 30 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The drugs are coded into two groups A and B by the assistant and then the table of random numbers is used as code A of even numbers and code B of odd numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs are coded by the assistant without the researcher's knowledge and the patient is aware of participating in the study but does not know which of the two drugs is used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
No 111, 7th Abrishami Alley
City
Shiraz
Province
Fars
Postal code
7147768518
Approval date
2020-06-21, 1399/04/01
Ethics committee reference number
IR.SUMS.DENTAL.REC.1399.061
Health conditions studied
1
Description of health condition studied
controlled hypertensive patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart rate
Timepoint
Before intervention and 10 , 30 minute after
Method of measurement
Pulse oximeter
2
Description
Blood pressure
Timepoint
Before intervention and 10 , 30 minute after
Method of measurement
Blood pressure monitor
3
Description
Blood oxygen saturation
Timepoint
Before intervention and 10 , 30 minute after
Method of measurement
Pulse oximeter
Secondary outcomes
1
Description
Stress score
Timepoint
before and after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: 16 patients with injection of perilocain 3%+ felypressin daru pakhsh
Category
Treatment - Drugs
2
Description
Intervention group: 16 patients with mepivacain hydrochlorid 3% eksir
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Dentistry University
Full name of responsible person
Ehsan Aliabadi
Street address
Dentistry University, Ghoaabad
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
dental@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ehsan Aliabadi
Street address
The central building of Shiraz University of Medical Sciences,in front of Palestine St,Zand St,Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۳۳۶
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
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
Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Homayoun
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
111 NO,7th alley,Abrishami St
City
Shiraz
Province
Fars
Postal code
7147768518
Phone
+98 71 3228 4031
Email
ahmad.homayoun9@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Homayoun
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
111 NO,7th alley,Abrishami St
City
Shiraz
Province
Fars
Postal code
7147768518
Phone
+98 71 3228 4031
Email
Ahmad.homayoun9@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Homayoun
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
111 NO,7th alley,Abrishami St
City
Shiraz
Province
Fars
Postal code
7147768518
Phone
+98 71 3228 4031
Email
ahmad.homayoun9@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Questionnaire, consent form, and data form
When the data will become available and for how long
Access period starts 6 months after printing
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers who are certified by academic and scientific institutions.
From where data/document is obtainable
Shiraz School of Dentistry
What processes are involved for a request to access data/document