Comparison of changes in Neutrophil-to-Lymphocyte Ratio (NLR) in patients with nausea vomiting and patients without nausea vomiting after spinal anesthesia
Comparison of changes in neutrophil to lymphocyte ratio in patients with nausea and vomiting and patients without nausea and vomiting
Design
The clinical trial, three blind, without randomization on 80 patients
Settings and conduct
This is a three-blind clinical trial that will be conducted on 80 candidates for spinal anesthesia at Kashani Hospital in Isfahan. After the approval of the ethics committee of the university and obtaining the consent of the patients, the patients are subjected to spinal anesthesia and blood samples are taken before and after the spinal and after the end of the operation. Also, the fourth sample, if the patient has nausea and vomiting, immediately after nausea or vomiting. And otherwise, it will be taken from recovery during discharge. The samples are collected in identical and coded tubes and sent to the laboratory immediately. 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. Laboratory experts and people who collect and analyze data do not know about the patient group and are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 65, ASA anesthesia class I and II, candidate for spinal anesthesia
Non-entry criteria: obesity, cardiovascular and hemodynamic diseases, drug and psychotropic addiction, pregnancy, and breastfeeding.
Intervention groups
In this study, 80 eligible patients were included in the study, and their condition was checked in terms of having or not having nausea and vomiting.
Main outcome variables
Neutrophil to lymphocyte ratio
General information
Reason for update
Acronym
NLR
IRCT registration information
IRCT registration number:IRCT20160307026950N42
Registration date:2022-07-13, 1401/04/22
Registration timing:prospective
Last update:2022-07-13, 1401/04/22
Update count:0
Registration date
2022-07-13, 1401/04/22
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
2022-07-23, 1401/05/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of changes in Neutrophil-to-Lymphocyte Ratio (NLR) in patients with nausea vomiting and patients without nausea vomiting after spinal anesthesia
Public title
Comparison of changes in Neutrophil-to-Lymphocyte Ratio (NLR) in patients with nausea vomiting and patients without nausea vomiting
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 spinal anesthesia
Informed consent to enter the study
Exclusion criteria:
BMI (Body Mass Index)>30
Cardiovascular diseases and hemodynamic disorders
Use of psychotropic or sedative drugs
Addiction to opioid and non-opioid drugs
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
Outcome assessor
Data analyser
Sample size
Target sample size:
80
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
In this study, 80 patients are considered and examined to determine how many patients have nausea and vomiting during the study.
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 St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-06-15, 1401/03/25
Ethics committee reference number
IR.MUI.MED.REC.1401.126
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Neutrophil to lymphocyte ratio
Timepoint
Before spinal, 20 minutes after spinal, when entering recovery, immediately after nausea and vomiting and when discharged from recovery
Method of measurement
Venous blood sample
Secondary outcomes
1
Description
Blood Pressure
Timepoint
Every 10 minutes from the moment of entering the operating room until the moment of discharge from the recovery
Method of measurement
Sphygmomanometer
2
Description
Heart Rate
Timepoint
From the moment of entering the operating room until the moment of discharge from the recovery
Method of measurement
Electrocardiogram
3
Description
Oxygen saturation
Timepoint
From the moment of entering the operating room until the moment of discharge from the recovery
Method of measurement
Pulse Oximeter
Intervention groups
1
Description
Intervention group: In this study, all 80 eligible patients are monitored after spinal surgery and their symptoms are recorded. Also, before and after spinal surgery and when entering recovery, cbc blood samples are taken from the patient to measure the Neutrophil to Lymphocyte Ratio. Then, in recovery, they are checked for nausea and vomiting, and if they had nausea and vomiting, the fourth sample is taken immediately after, otherwise, when they are discharged from recovery.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Behzad Nazemoroaya
Street address
Kashani St
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
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
Mahmud Falamarz Fuladi
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
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 assistant 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
Leyla Rafiei
Position
Nurse Anesthetist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3620 2020
Email
Leylarafiei943@gmail.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