Comparison of the effect of Etomidate with Sodium Thiopental on sore throat and muscular pain following surgery under general anesthesia
Design
This study is a clinical trial study.
Samples of this study were 112 patients of Imam Hossein Hospital operating room, which have been prepared for open surgery under general anesthesia with endotracheal intubation.
After justification and informed consent, the patients are prepared according to a simple random pattern and will be placed in one of the Etomidate groups (group A or intervention) or thiopental (group B or control)
Settings and conduct
This research was conducted on comparison of the effect of Etomidate with Sodium Thiopental on sore throat and muscular pain following surgery under general anesthesia.
The place of research is in the operating room of Imam Hossein Hospital. After justification and informed consent, the patients will be placed in one of the Etomidate (group A or intervention) or Thiopental (group B or control), based on the simple randomized pattern prepared beforehand.
The study is a double-blind, and the participants, the main researcher, the Study not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A woman or man aged 18 to 50 years, The risk of anesthesia is one and two
exclusion criteria: History of drug abuse, They need to inject a succinylcholine drug, Any complications of anesthesia or surgery that occur during the procedure
Intervention groups
Intervention group: The onset of anesthesia with an Etomidate (0.3 mg / kg) and muscle relaxant in the the intervention group, Atracurium (0.4 mg / kg) will be performed by the skilled person.
Control group: The onset of anesthesia with Thiopental (5 mg / kg) and muscle relaxant in the control group, Atracurium (0.4 mg / kg) will be performed by the skilled person.
Main outcome variables
Sore throat and muscle aches
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160217026614N2
Registration date:2018-02-20, 1396/12/01
Registration timing:registered_while_recruiting
Last update:2018-02-20, 1396/12/01
Update count:0
Registration date
2018-02-20, 1396/12/01
Registrant information
Name
ehsan zeinali
Name of organization / entity
medical university of shahrud
Country
Iran (Islamic Republic of)
Phone
+98 23 3236 9764
Email address
zeinali_ehsan@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-19, 1395/12/29
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Etomidate with Sodium Thiopental on sore throat and muscular pain following surgery under general anesthesia.
Public title
Comparison of the effect of Etomidate with Sodium Thiopental on sore throat and muscular pain following surgery under general anesthesia.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A woman or man aged 18 to 50 years
The risk of anesthesia is one and two
Exclusion criteria:
History of drug abuse
They need to inject a succinylcholine drug
Any complications of anesthesia or surgery that occur during the procedure
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization based on simple random pattern that is performed using a random number table.
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 ُShahrud medical sience
Street address
Shahroud University of Medical Sciences and Health Services, Hafte-Tir Square, Shahroud
City
shahrud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۷
Approval date
2016-01-12, 1394/10/22
Ethics committee reference number
IR.SHmu.REC.1394.168
Health conditions studied
1
Description of health condition studied
Complications of anesthesia
ICD-10 code
T88.59XD
ICD-10 code description
Other complications of anesthesia, subsequent encounter
Primary outcomes
1
Description
Sore throat
Timepoint
The first day after the intervention
Method of measurement
NPRS benchmark
2
Description
muscle aches
Timepoint
The first day after the intervention
Method of measurement
NPRS benchmark
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The onset of anesthesia with an Etomidate (0.3 mg / kg) and muscle relaxant in the the intervention group, Atracurium (0.4 mg / kg) will be performed by the skilled person.
Category
Treatment - Surgery
2
Description
Control group: The onset of anesthesia with Thiopental (5 mg / kg) and muscle relaxant in the control group, Atracurium (0.4 mg / kg) will be performed by the skilled person.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Shahroud Hospital
Full name of responsible person
Ehsan Zainali
Street address
Lane 28-meter Ayatollah Tohidi ,Imam Street. Shahrood City
City
Shahroud
Province
Semnan
Postal code
3615687183
Phone
+98 23 3234 2000
Email
zeinali_ehsan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3234 2000
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Ehsan Zainali
Position
Student of Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Province
Semnan
Postal code
3615687183
Phone
+98 23 3234 5591
Email
zeinali_ehsan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ehsan Zainali
Position
Student of Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Province
Semnan
Postal code
3615687183
Phone
+98 23 3234 5591
Email
zeinali_ehsan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ehsan Zainali
Position
Student of Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Health Services,Hafte-Tir Square,Shahroud
City
Shahroud
Province
Semnan
Postal code
3615687183
Phone
+98 23 3234 5591
Email
zeinali_ehsan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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