Investigating the comparative of pain intensity due to intravenous injection of thiopental sodium, propofol, diazepam and etomidate during induction of general anesthesia
Determination of pain intensity due to intravenous injection of sodium thiopental, propofol, diazepam and etomidate during the induction of general anesthesia
Design
.According to the objectives and type of study and based on previous studies in this field and with the formula and taking into account the assumptions: 5% error and 80% power, 43 people in each group were estimated. Considering the probability of a fall, using the formula, the total sample size was 200 people (50 people in each group).
Settings and conduct
200 selected patients (in 1399) will be selected as available samples and will be randomly divided into four intervention groups based on random blocks and in parallel. In each patient, the demographic questionnaire will be filled in first, and then the pain assessment scale, which is a self-reporting scale, will be measured for each patient at the same time as the injection of the drug being studied while inducing anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Having general anesthesia conditions based on pre-anesthesia examinations
2. Age 15 to 50 years
3. The surgery is optional
4 . Having the risk of anesthesia I and II
5. Do not have drug addiction
6. Do not have mental disorders based on pre-anesthesia examinations
7. Do not have of diabetic disease
8. Do not have systemic neurological disease
Exclusion criteria:
Non-cooperation of research units with researchers
Intervention groups
Intervention 1: Diazepam is taken as a precursor and no medication has been taken before.
Intervention 2: Thiopenthal is taken as a precursor and no medication is taken beforehand.
Intervention 3:They take propofol as a precursor and do not take any medication beforehand
Intervention 4: Etomidate is taken as a precursor and no medication is taken beforehand
Main outcome variables
Injection pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190822044581N2
Registration date:2020-04-29, 1399/02/10
Registration timing:prospective
Last update:2020-04-29, 1399/02/10
Update count:0
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Naeem Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3222 3853
Email address
naiem.abdi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the comparative of pain intensity due to intravenous injection of thiopental sodium, propofol, diazepam and etomidate during induction of general anesthesia
Public title
Investigating the comparative of pain intensity due to intravenous injection of thiopental sodium, propofol, diazepam and etomidate during induction of general anesthesia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having general anesthesia based on pre-anesthesia examinations
Age 15 to 50 years
The surgery is optional
4 - having the risk of anesthesia I and II
Do not have drug addiction
Do not have mental and psychological disorders based on pre-anesthesia examinations
Do not have diabetic disease
Do not have systemic neurological disease
Exclusion criteria:
Non-cooperation of research units with researchers
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
N/A
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
Yasuj University of Medical Sciences
Street address
Motahari street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.YUMS.REC.1398.167
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Injection pain
Timepoint
Simultaneously with intravenous injection of the drug
Method of measurement
Pain measurement scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Diazepam is given as a pre-medication at a dose of 0.1 mg / kg and with a volume of 5 cc intravenously and no medication is taken beforehand. Simultaneously with the injection, the severity of the pain is measured by a pain measurement scale, which is a self-reporting scale. After the above medicine, other anesthetic drugs are injected and the patient is anesthetized. This drug is produced by Abu Reihan-Iran Pharmaceutical Company
Category
Treatment - Drugs
2
Description
Second Intervention Group: Sodium thiopental drug is administered intravenously at a dose of 3 mg / kg and with a volume of 5 cc as a sleeping drug and no medication is taken beforehand. Simultaneously with the injection, the severity of the pain is measured by a pain measurement scale, which is a self-reporting scale. After the above medicine, other anesthetic drugs are injected and the patient is anesthetized. This drug is produced by Abu Reihan-Iran Pharmaceutical Company
Category
Treatment - Drugs
3
Description
Third intervention group: Propofol is administered intravenously as a sleeping drug at a dose of 1 mg / kg and with a volume of 5 cc and no medication has been taken before. Simultaneously with the injection, the severity of the pain is measured by a pain measurement scale, which is a self-reporting scale. After the above medicine, other anesthetic drugs are injected and the patient is anesthetized. This drug is produced by Abu Reihan-Iran Pharmaceutical Company
Category
Treatment - Drugs
4
Description
Fourth Intervention Group: etomidate drug is administered intravenously at a dose of 0.3 mg / kg and with a volume of 5 cc as a sleeping drug and no medication is taken beforehand. Simultaneously with the injection, the severity of the pain is measured by a pain measurement scale, which is a self-reporting scale. After the above medicine, other anesthetic drugs are injected and the patient is anesthetized. This drug is produced by Abu Reihan-Iran Pharmaceutical Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Yasuj
Full name of responsible person
Naeem Abdi
Street address
Motahari street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Phone
+98 74 3222 3853
Email
abdi.naeim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Naeem Abdi
Street address
Motahari street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Phone
+98 74 3222 3853
Email
abdi.naeim@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
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
Yasouj University of Medical Sciences
Full name of responsible person
Naeem Abdi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Motahari street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Phone
+98 74 3222 3853
Email
abdi.naeim@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Naeem Abdi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Motahari street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Phone
+98 74 3222 3853
Email
abdi.naeim@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Naeem Abdi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Motahari street
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
1111111111
Phone
+98 74 3222 3853
Email
abdi.naeim@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD