Protocol summary

Study aim
Comparison between Induction of Anesthesia with Atomidate and Propofol on Surgical Stress Responses
Design
In this double-blind clinical trials study, 60 patients undergoing spinal surgery were randomly divided into three groups: the first intervention group (recipient of Atomidate) and the second group (recipient of Propofol) and control.
Settings and conduct
In this study, 60 patients who were candidates for spinal surgery in Golestan Hospital in Ahvaz were selected as available and were divided into three groups of first and second intervention and control in a simple random method. In the first intervention group, 0.3 mg/kg of atomidate and in the second intervention group, 2.2 mg / kg propolis was injected intravenously for induction. The control group also receives routine medications such as sodium thiopental 5 mg/kg. In order to conduct a two-way blind study, patients and researchers who take blood samples do not know which drug groups 1 and 2 and which group received the routine drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:Patients are candidates for spinal elective surgery, Lack of bacterial or viral infection, Lack of autoimmune diseases, connective tissue disease, peripheral vascular disease, liver and kidney disorders, heart failure, and mental disorders and Exclusion criteria include: dissatisfaction to continue participating in this study.
Intervention groups
In the first intervention group, 0.3 mg / kg of Atomidate and in the second intervention group, 2.2 mg / kg Propofol was injected intravenously for induction.The control group also receives routine medications such as 5 mg/kg sodium Thiopental.
Main outcome variables
Patients who entered the study, screened for serum IL-1 and IL-6 levels, albumin, glucose, Crp, and cortisone were measured immediately before surgery and anesthesia, 24 hours, 48 hours, and one week after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190506043492N5
Registration date: 2020-07-07, 1399/04/17
Registration timing: retrospective

Last update: 2020-07-07, 1399/04/17
Update count: 0
Registration date
2020-07-07, 1399/04/17
Registrant information
Name
Milad Arabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
arabi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2018-07-11, 1397/04/20
Actual recruitment end date
2020-03-10, 1398/12/20
Trial completion date
2020-03-14, 1398/12/24
Scientific title
Comparison of induction of anesthesia with etomidate and propofol on surgical stress responses in spinal elective surgery
Public title
Induction of anesthesia with etomidate and propofol on surgical stress responses
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of severe bacterial or chronic viral infection Do not take antidepressants Lack of autoimmune diseases Lack of connective tissue disease Lack of liver and kidney disorders Lack of peripheral vascular disease, heart failure, thyroid disease Lack of mental disorders
Exclusion criteria:
Dissatisfaction with continuing to study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly selected and randomly divided into two groups (Atomidate receiver) and the second group (Propofol receiver) through random number tables, so that for the first group, individual numbers were used and for the second group, even numbers were used.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients were unaware that they were in the atomidate group or propofol, a person who took a blood sample to check for laboratory tests related to the patient's stress response, and a statistical analyzer who did not know the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357157941
Approval date
2019-10-30, 1398/08/08
Ethics committee reference number
IR.AJUMS.REC.1398.561

Health conditions studied

1

Description of health condition studied
Stress Rresponse
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
Serum level IL-1
Timepoint
Immediately before surgery and anesthesia, 24 hours, 48 hours and one week after surgery
Method of measurement
IL-1 blood serum levels in a blood biochemistry test

2

Description
Serum level IL-2
Timepoint
Immediately before surgery and anesthesia, 24 hours, 48 hours and one week after surgery
Method of measurement
Blood serum IL-2 levels in a blood biochemistry test

3

Description
Serum albumin levels
Timepoint
Immediately before surgery and anesthesia, 24 hours, 48 hours and one week after surgery
Method of measurement
Serum levels of blood albumin in a blood biochemistry test

4

Description
Serum glucose levels
Timepoint
Immediately before surgery and anesthesia, 24 hours, 48 hours and one week after surgery
Method of measurement
Serum blood glucose levels in a blood biochemistry test

5

Description
C-reactive-protein (Crp) Level
Timepoint
Immediately before surgery and anesthesia, 24 hours, 48 hours and one week after surgery
Method of measurement
Serum Crp blood levels in blood biochemistry tests

6

Description
Serum cortisol levels
Timepoint
Immediately before surgery and anesthesia, 24 hours, 48 hours and one week after surgery
Method of measurement
Serum levels of blood cortisol in a blood biochemistry test

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group:In order to induce anesthesia, 0.3 mg / kg of atomidate (oxy-nac, Elixir Pharmaceuticals, Boroujerd, Iran) were injected intravenously.
Category
Prevention

2

Description
Second Intervention group: In order to induce anesthesia, 2.2 mg / kg of propofol (Oxy-Nak, Elixir Pharmacy, Boroujerd, Iran) was injected intravenously.
Category
Prevention

3

Description
Control group: In order to induce anesthesia, 5 mg / kg sodium thiopental (Oxy-Nak, Elixir Pharmacy, Boroujerd, Iran) was injected intravenously.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Mohamad Mahdi Mina
Street address
Golestan Hospital, Golestan Boulevard
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Mahdi552m@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Vice Chancellor For Research of Ahvaz Jundishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Mahdi552m@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamad Mahdi Mina
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Mahdi552m@hotmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Farahzad Janat Makan
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Fjanatmakan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamad Mahdi Mina
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Mahdi552m@hotmail.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
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