Comparing the effect of laryngoscopy on hemodynamic status and Neutrophil to Lymphocyte Ratio (NLR)after induction of anesthesia Ethomidite, Propofol and Ketamine
Comparing the effect of laryngoscopy on hemodynamic status and Neutrophil to Lymphocyte Ratio (NLR)after induction of anesthesia Ethomidite, Propofol and Ketamine
Design
The clinical trial, three blind, without randomization on90 patients
Settings and conduct
This is a three-blind clinical trial that will be conducted on 90 patients who are candidates for general anesthesia at Al-Zahra Hospital in Isfahan. After the approval of the ethics committee of the university and obtaining the consent of the patients, the patients are put under anesthesia and blood samples are taken before and after intubation and after the end of the operation and when they are discharged from recovery. The samples are collected in identical and coded tubes and sent to the laboratory immediately. The clinical symptoms of the patient are monitored and recorded from the moment of entering the operating room until the moment of leaving the recovery room.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 65, ASA anesthesia class I and II, candidate for general anesthesia
Non-entry criteria: obesity, cardiovascular and hemodynamic diseases, drug and psychotropic addiction, pregnancy, and breastfeeding.
Intervention groups
Intervention group: In this study, all 90 eligible patients are monitored after general anesthesia and their symptoms are recorded. Also, before and after general anesthesia and when entering recovery, cbc blood samples are taken from the patient to measure the Neutrophil to Lymphocyte Ratio.
Main outcome variables
Neutrophil to lymphocyte ratio
General information
Reason for update
Acronym
NLR
IRCT registration information
IRCT registration number:IRCT20160307026950N56
Registration date:2023-12-25, 1402/10/04
Registration timing:registered_while_recruiting
Last update:2023-12-25, 1402/10/04
Update count:0
Registration date
2023-12-25, 1402/10/04
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of laryngoscopy on hemodynamic status and Neutrophil to Lymphocyte Ratio (NLR)after induction of anesthesia Ethomidite, Propofol and Ketamine
Public title
Comparing the effect of laryngoscopy on hemodynamic status and Neutrophil to Lymphocyte Ratio (NLR)after induction of anesthesia Ethomidite, Propofol and Ketamine
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 60 years old
Anesthesia class I and II according to ASA criteria
Candidate for surgery under general anesthesia
Informed consent to enter the study
Exclusion criteria:
Hemodynamic disorders Use of psychotropic or sedative drugsAddiction to opioid and non-opioid drugs
BMI (Body Mass Index)>30Cardiovascular diseases
Pregnancy and breastfeeding
Having diabetes, orthostatic hypotension, bradycardia, hypokalemia, hypothyroidism, depression, long QT syndrome
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
This is a three-way blind clinical trial so that before obtaining consent, the patients are included in the study, but the patient does not know which people are included in the study, and it is assumed that the conditions are the same for everyone, the samples are also inside the tube. Identical forms that only have the characteristics and code of the patient group are placed so that the laboratory experts are also kept blind, those responsible for collecting data, and those who evaluate the outcome also do not know about the patient group are blind.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-10-23, 1402/08/01
Ethics committee reference number
IR.MUI.MED.REC.14020271
Health conditions studied
1
Description of health condition studied
Neutrophil Lymphocyte ratio
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Neutrophil to lymphocyte ratio
Timepoint
Before anesthesia, after intubation, 20min after general anesthesia, enterance to the recovery unit
Method of measurement
Venous blood sample
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Before anesthesia, after intubation, 20min after general anesthesia, enterance to the recovery unit
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Intervention group: In this study, all 90 eligible patients are monitored after general anesthesia and their symptoms are recorded. Also, before and after general anesthesia and when entering recovery, cbc blood samples are taken from the patient to measure the Neutrophil to Lymphocyte Ratio.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad Nazemoroaya
Street address
Soffe street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 0000
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Peyman Farhanian
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8143743561
Phone
+98 31 3212 3974
Email
Leylarafiei943@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazem roaya
Position
Professor associate of Anesthesia and Intensive carentensive care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
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
There is no more information
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