Comparison of hemodynamic changes during induction of anesthesia between two drugs, succinylcholine and Rocuronium, in affiliated hospitals of Tehran Islamic Azad University of Medical Sciences, 2023-2024
Design
Clinical trial with control and intervention group, with parallel groups, single-blind, randomized, phase 3 on 50 patients, random number table was used for randomization.
Settings and conduct
Our target population in this study is patients who volunteer for surgery with general anesthesia who refer to affiliated hospitals of Tehran Azad University of Medical Sciences during 2023-2024 and are in ASA1 and ASA2 anesthesia classes. In this study, as the principal investigator, we compare the effects of two drugs, succinylcholine and rocuronium, for induction of anesthesia based on hemodynamic changes at 1, 10, and 20 minutes. This is a single- blind and parallel study in It is done in two groups of 19 people.
Participants/Inclusion and exclusion criteria
Entry criteria; Referees to the operating room of affiliated hospitals of Tehran Azad University of Medical Sciences for surgery with general anesthesia Patients with anesthesia class ASA1 and ASA2
Excit criteria: Patients' lack of consent to participate in the study Patients with a history of sensitivity or other contraindications to the drugs used Patients with a history of trauma in the last 72 hours Complications of anesthesia or surgery.
Comparison of hemodynamic changes during induction of anesthesia between Succinylcholine and Rocuronium
Public title
Comparison of hemodynamic changes during induction of anesthesia between Succinylcholine and Rocuronium
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Referees to the operating room of affiliated hospitals of Tehran Azad University of Medical Sciences for surgery with general anesthesia
Patients with anesthesia class ASA1 and ASA2
Exclusion criteria:
Patients' lack of consent to participate in the study
Patients with a history of sensitivity or other contraindications to the drugs used
Patients with a history of trauma in the last 72 hours
Complications of anesthesia or surgery
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Simple Randomization
Randomization Unit: Individual
Randomization tool: table of random numbers
Random sequence generation: Online Randomization
Allocation Concealment: Sequentially numbered, sealed, opaque envelopes
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient receives the drug (intervention or comparison group) in sealed envelopes that are coded. Coding is done by the researcher. The study is single-blinded and only the patient is blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of azad unversity of medical sciences branch of tehran
Street address
West golha
City
Andishe
Province
Tehran
Postal code
3354914015
Approval date
2023-08-13, 1402/05/22
Ethics committee reference number
IR.IAU.TMU.REC.1402.139
Health conditions studied
1
Description of health condition studied
Heart Beat
ICD-10 code
R00
ICD-10 code description
Abnormalities of heart beat
2
Description of health condition studied
Blood Pressure
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis
Primary outcomes
1
Description
Heart rate ,blood pressure
Timepoint
Hemodynamic changes in 1, 10 and 20 minutes after anesthesia
Method of measurement
Cardiac monitoring device and sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the first group, rocuronium at the rate of 0.3 mg/kg along with sodium thiopental anesthetics at the rate of 5 mg/kg and prodrug fentanyl (2 cc), midazolam (2 mg/kg) with a tracheal tube suitable for induction and intubation is done
Category
Rehabilitation
2
Description
Control group: in the second group, succinylcholine at the rate of 1.5 mg per kg along with sodium thiopental anesthetics at the rate of 5 mg per kg and prodrug fentanyl (2 cc), midazolam (2 mg per kg) with a suitable endotracheal tube Induction and intubation are performed
Headquarters Building of Tehran Islamic Azad University of Medical Sciences, Corner of Gol Yakh St, Ayene Blvd., Amir Pabarja St., Dr. Shariati St., Tehran
City
Tehran
Province
Tehran
Postal code
194963588
Phone
+98 21 2660 2642
Fax
+98 21 2200 4781
Email
Mparsania@iautmu.ac.ir
Web page address
https://tms.iau.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr. Heidar Darvishi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amirulmominin Hospital, Sardar Jangal Park, Shahid Shirmohammadi St., Naziabad, Tehran
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6550
Email
dr_hdarvishi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Heidar Darvishi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amirulmominin Hospital, Sardar Jangal Park, Shahid Shirmohammadi St., Naziabad, Tehran
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6550
Email
dr_hdarvishi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Khalili
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No.15, Block B, Almas Complex, 1st Osatd Foruzanfar St., West Golha Blvd., Andishe Phase 4, Tehran
City
Tehran
Province
Tehran
Postal code
3354914015
Phone
+98 21 6535 2028
Email
majidkhalili258@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