Protocol summary

Study aim
Comparison of hemodynamic changes and Neutrophil to Lymphocyte Ratio changes caused by Atracurium and Ais-Atracurium injection.
Design
A clinical trial with parallel groups, double-blind, randomized, phase 2 on 80 patients. randomization will be done using a coin toss.
Settings and conduct
This is a randomized double-blind clinical trial that will be conducted on 80 patients in Al-Zahra Hospital, Isfahan. After the approval of the ethics committee of the university and obtaining the consent of the patients, the patients are randomly assigned into groups, the desired intervention is applied in each group, and the blood samples and clinical symptoms of the patient are examined and recorded. The researcher who records the patient's symptoms, laboratory experts, the analyzers, as well as the patients won't know the type of intervention applied in each group and therefore they are all blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 65 years, class I and II ASA anesthesia, informed consent, and candidate for general anesthesia with Atracurium and Cis-Atracurium Non-Inclusion criteria: history of heart disease and hemodynamic disorders, drug addiction, use of psychedelics, antihistamines, and corticosteroids in the last week, obesity, diabetes, pregnancy, and breastfeeding.
Intervention groups
Intervention group A: In this group of patients, after preparation and connection of monitoring, Sodium Thiopental 5 mg/kg as an anesthetic, Fentanyl 100 micrograms as an analgesic, and also for muscle relaxation 0.5 mg/kg Atracurium within 60 seconds. Intervention group B: In this group of patients, after preparation and connection of monitoring, Sodium Thiopental 5 mg/kg as an anesthetic, Fentanyl 100 micrograms as an analgesic, and also for muscle relaxation 0.15 mg/kg Cis-Atracurium within 60 seconds.
Main outcome variables
Heart Rate, Blood Pressure, Spo2, NLR

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160307026950N48
Registration date: 2022-12-11, 1401/09/20
Registration timing: registered_while_recruiting

Last update: 2022-12-11, 1401/09/20
Update count: 0
Registration date
2022-12-11, 1401/09/20
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
2022-11-06, 1401/08/15
Expected recruitment end date
2023-01-05, 1401/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Atracurium and Cis-Atracurium injection on hemodynamic status and Neutrophil-to-Lymphocyte Ratio (NLR) during anesthesia induction
Public title
The effect of Atracurium and Cis-Atracurium injection on hemodynamic status and Neutrophil-to-Lymphocyte Ratio (NLR) during anesthesia induction
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 65 years old Anesthesia class I and II according to ASA criteria Candidate for anesthesia with Atracurium and Cis-Atracurium Informed consent to enter the study
Exclusion criteria:
Obesity or BMI (Body Mass Index) of more than 30 History of cardiovascular diseases and hemodynamic disorders or myocardial infarction in the last 6 months Taking psychoactive drugs, antihistamines and corticosteroids in the last week Addiction to opioid and non-opioid drugs Pregnancy and breastfeeding Having diabetes, orthostatic hypotension, bradycardia, hypokalemia, hypothyroidism, depression, long QT syndrome, asthma and allergies
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)
Randomized
Randomization description
This is a simple randomized clinical trial that patients are divided into groups based on flipping a coin; After the first flip of the coin, for the first patient, atracurium is selected for injection in the case of heads, and in the case of tails, cis atracurium is selected. Then, from the second patient onwards, individuals enter the groups one by one until the number reaches 40 people in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind clinical trial so that, before obtaining consent, the patients will be informed of the study but will not be informed about the type of intervention received. Also, the researchers responsible for collecting and analyzing the data won't be informed about the intervention group; therefore, they are all blind.
Placebo
Not used
Assignment
Parallel
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 St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.MUI.MED.REC.1401.230

Health conditions studied

1

Description of health condition studied
Change in hemodynamic status and NLR
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Heart Rate
Timepoint
before induction of anesthesia and at 3, 10, and 20 minutes after anesthesia
Method of measurement
Electrocardiogram

2

Description
Blood Pressure
Timepoint
before induction of anesthesia and at 3, 10, and 20 minutes after anesthesia
Method of measurement
Sphygmomanometer

3

Description
Oxygen saturation
Timepoint
before induction of anesthesia and at 3, 10, and 20 minutes after anesthesia
Method of measurement
Pulse Oximeter

4

Description
Neutrophil to lymphocyte ratio
Timepoint
before induction of anesthesia and at 3, 10, and 20 minutes after anesthesia
Method of measurement
Cell count of venous blood sample

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: In this group, after placing the patients on the surgical bed and connecting the monitoring and establishing two suitable intravenous lines, the first venous blood sample is taken for cell counting and the patient's initial clinical symptoms are measured and recorded. Then, 5 mg/kg Sodium Thiopental made by Elixir Pharmaceutical Company, 100 micrograms of Fentanyl made by Caspin Pharmaceutical Company and 0.5 mg/kg of Atracurium made by Aburihan Pharmaceutical Company are injected to induce anesthesia. Sampling and recording of symptoms are also done in 3, 10 and 20 minutes after anesthesia.
Category
Diagnosis

2

Description
Intervention group B: In this group, after placing the patients on the surgical bed and connecting the monitoring and establishing two suitable intravenous lines, the first venous blood sample is taken for cell counting and the patient's initial clinical symptoms are measured and recorded. Then, 5 mg/kg Sodium Thiopental made by Elixir Pharmaceutical Company, 100 micrograms of Fentanyl made by Caspin Pharmaceutical Company and 0.15 mg/kg of Cis-Atracurium made by Aburihan Pharmaceutical Company are injected to induce anesthesia. Sampling and recording of symptoms are also done in 3, 10 and 20 minutes after anesthesia.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
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
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 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 careاستادیار بیهوشی و مراقبت های ویژه د
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
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