Protocol summary

Study aim
Determination of the possibility of painful movement before tracheal intubation
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on the examined patients, and the RAND function of Excel software was used for randomization.
Settings and conduct
Patients in operation rom in Emam khomeni after the injection of fentanyl (2 mcg per kilogram of body weight) and midazolam (0.03 mg per kilogram of body weight) and sodium thiopental induction drug (at the rate of 5 mg per kilogram of body weight and Etracurium half milligram) grams per kilogram of body weight) blood pressure and heart rate were again measured and the depth of anesthesia was monitored. If the depth of anesthesia is between 40 and 60, the patient underwent Foley catheterization and after that all parameters were measured and recorded again, and then after 3 minutes tracheal intubation was performed and again blood pressure including systolic blood pressure and Diastole and mean arterial pressure were measured by monitoring the depth of anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria : 1. Laparotomy candidate patients 2. Completing and signing the informed consent form Exclusion criteria: 1. Concurrent participation in other studies 2. Dissatisfaction with the study 3. Patients with a history of heart disease, high blood pressure, diabetes and other systemic diseases 4. Patients who had previous problems with intubation.
Intervention groups
Intervention (after monitoring and drug injection, they first underwent urethral catheterization and then tracheal intubation) Controls (they underwent tracheal intubation)
Main outcome variables
Systolic pressure, Diastole, mean arterial pressure, Heart rate and depth of anesthesia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170709034978N3
Registration date: 2024-04-09, 1403/01/21
Registration timing: retrospective

Last update: 2024-04-09, 1403/01/21
Update count: 0
Registration date
2024-04-09, 1403/01/21
Registrant information
Name
Mojgan Rahimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84426391
Email address
mrahimi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-20, 1401/12/29
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
2023-03-20, 1401/12/29
Actual recruitment end date
2023-07-22, 1402/04/31
Trial completion date
2023-07-22, 1402/04/31
Scientific title
Evaluation of the possibility of performing painful stimulations before endotracheal intubation based on insufflation Hemodynamic changes and monitoring of anesthesia depth in patients under general anesthesia
Public title
Evaluation of the possibility of performing painful stimulations before endotracheal intubation based on insufflation Hemodynamic changes and monitoring of anesthesia depth in patients under general anesthesia
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Laparotomy candidate patients Completing and signing the informed consent form
Exclusion criteria:
Concurrent participation in other studies Dissatisfaction with the study Patients with a history of heart disease, high blood pressure, diabetes and other systemic diseases Patients who had previous problems with intubation
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation is done based on the block of four numbers prepared by Excel software. In this method, the numbers are divided into groups of four and then one number is randomly selected from each group. This method ensures that each group of numbers is randomly selected and ensures random assignment in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-scored blinding in this study is as follows: The professor who guides the study knows how to perform the probing process (painful stimulation) and identifies the patients who have been probed. He is also responsible for investigating hemodynamic changes and monitoring the depth of anesthesia in patients under general anesthesia. The visiting nurse who is responsible for performing sounding in patients, acts completely unaware of the research and the main purpose of the study. He is only acting according to the therapist's orders and treatment plan, and is not aware that this action was taken to investigate the effect of painful stimuli before tracheal intubation. The patients who have been probed are also unaware of the probe and the main purpose of the study. They are treated only as patients under general anesthesia and do not know whether painful stimulation was performed before tracheal intubation. Only the supervisor (scientific consultant) who participates in the research is aware of the probing and the patients who have been subjected to these painful stimulations. He is responsible for supervising the correct implementation of the research and provides technical and scientific guidance. In this way, in this double-blind method, the main researcher, the patients, and the attending nurse act separately without knowing the details of the survey and research, and only the supervisor has complete information. This method is used in order to maintain blinding and the scientific validity of the study results.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Imam Khomeini hospital(rah)
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-09-29, 1399/07/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.243

Health conditions studied

1

Description of health condition studied
Hemodynamic changes
ICD-10 code
A41.3
ICD-10 code description
hemodynamic

Primary outcomes

1

Description
Depth of anesthesia
Timepoint
Before and after induction, before and after catheterization and after tracheal intubation
Method of measurement
Checking the monitor connected to the patient.

2

Description
Hemodynamic changes
Timepoint
Before and after induction, before and after catheterization and after tracheal intubation
Method of measurement
Checking the monitor connected to the patient.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention grouAfter monitoring and drug injection, they first underwent urethral catheterization and then tracheal intubation.p:
Category
Treatment - Devices

2

Description
Control group: Routinely, after monitoring and drug injection, there was no irritation until tracheal intubation
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini copmlex hospital
Full name of responsible person
Mojgan Rahimi
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 921 296 2566
Email
mrahimi@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbri sar
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 8873 8102
Fax
+98 21 6658 1537
Email
akbarisari@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Tehran University of Medical Sciences
Position
Mojgan Rahimi
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2620
Email
mrahimi@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Rahimi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2620
Email
mrahimi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Rahimi
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2620
Email
mrahimi@tums.ac.ir

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Not applicable
When the data will become available and for how long
Not applicable
To whom data/document is available
Not applicable
Under which criteria data/document could be used
Not applicable
From where data/document is obtainable
Not applicable
What processes are involved for a request to access data/document
Not applicable
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