Determination of the effect of fentanyl and morphine on hemodynamic changes during abdominal surgery
Design
The clinical trial has a control group (receiving fentanyl) and a control group (receiving morphine) with parallel, double-blind, randomized phase 3 groups on 36 patients.
Excel software rand function was used for randomization.
Settings and conduct
In this study, which will be conducted as a clinical trial, 36 patients who are candidates for abdominal surgery in patients referred to Amir Al-Momenin Hospital in Tehran during the years 1399-1400 are included in the study. Demographic information of patients, including demographic characteristics, clinical information and indicators Patients will be observed and collected in the laboratory.
Hops specimen is performed by establishing a suitable intravenous route and complete monitoring by injecting 2 mg midazolam 3 cc fentanyl and thiopental and atracurium induction of anesthesia. Gram is injected per hour and hemodynamic changes are measured and data analysis is performed with SPSS software version 25.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Complete information of the participants
2. Age 18 years and older
3. Candidate for abdominal surgery
Exclusion criteria:
1. Psychiatrists
2. Drug addiction
3. Cardiovascular diseases and blood pressure
Intervention groups
The clinical trial has a control group (receiving fentanyl) and a control group (receiving morphine).
Determination of the effect of fentanyl and morphine on hemodynamic changes during abdominal surgery in Amir Al-Momenin Hospital, Tehran
Community Verified icon
Evaluation of the effect of fentanyl and morphine on hemodynamic changes during abdominal surgery
Public title
Evaluation of the effect of fentanyl and morphine on hemodynamic changes during abdominal surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
complete identity profile
age 18 years and higher
candidates for abdominal surgery
Exclusion criteria:
psychiatric drug users
opioid drug addict
cardio vascular disease, hypertension
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
36 patients who are candidates for abdominal surgery referred to Amir Al-Momenin Hospital in Tehran during the years 1399-1400 are available to study
Each person is randomly assigned to one of two groups
The randomization method is simple and individual randomization unit
The tool used in randomization is Excel software
Blinding (investigator's opinion)
Double blinded
Blinding description
Both groups participating in the clinical trial (morphine group and fentanyl group) enter the trial randomly.
The drugs are taken in two syringes and equal volumes, and in the form of a score of 1, 2, or a and b, which the collector does not know, as well as the surgeon and the patient, so he is both blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences
Street address
No4, 6 west boostan alley, 35 lale Ave, Marzdaran Blvd, Tehran town
City
Tehran
Province
Tehran
Postal code
1461776195
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
IR.IAU.TMU.REC.1400.002
Health conditions studied
1
Description of health condition studied
pulse rate changes
ICD-10 code
R00
ICD-10 code description
Abnormalities of heart beat
2
Description of health condition studied
respiratory rate changes
ICD-10 code
R09
ICD-10 code description
Other symptoms and signs involving the circulatory and respiratory system
3
Description of health condition studied
blood pressure changes
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis
Primary outcomes
1
Description
blood pressure changes
Timepoint
Evaluation of blood pressure changes in the first 10 minutes after induction of anesthesia and then the average changes per hour of operation and recoveryCommunity Verified icon
Method of measurement
vital sign monitoring
2
Description
pulse rate
Timepoint
Evaluation of pulse rate changes in the first 10 minutes after induction of anesthesia and then the average changes per hour of operation and recoveryCommunity Verified icon
Method of measurement
vital sign monitoring
3
Description
respiratory rate
Timepoint
Evaluation of respiratory rate changes in the first 10 minutes after induction of anesthesia and then the average changes per hour of operation and recoveryCommunity Verified icon
Method of measurement
vital sign monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After establishing a proper venous route and complete monitoring, anesthesia is induced by injection of 2 mimidazolam, 3 cc of fentanyl, thiopental and atracurium, and then 1 cc of fentanyl is injected every hour and hemodynamic changes are measured.Community Verified icon
Category
Treatment - Drugs
2
Description
Control group: After establishing a proper venous route and complete monitoring, anesthesia is induced by injection of 2 mimidazolam, 3 cc of fentanyl, thiopental and atracurium, and then 2 mg of morphine is injected every hour and hemodynamic changes are measured.Community Verified icon
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-momenin Hospital
Full name of responsible person
Mahtab Barkhabeh
Street address
Amiral momenin hospital,Shimohammadi Ave,Nazi abad st,Tehran town
City
Tehran
Province
Tehran
Postal code
1811694784
Phone
+98 21 5534 6552
Email
amhos@iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shabnam Movaseghi
Street address
Islamic azad university of tehran,Daneshgar Ave, zargande ,Tehran Town
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
mahtabbarkhabeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Tehran, Medical branch
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahtab Barkhabeh
Position
Medical student(intern)
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No4, 6 west boostan,35 laleh Ave,Marzdaran blvd,Tehran town
City
Tehran
Province
Tehran
Postal code
1461776195
Phone
+98 21 4426 4451
Email
mahtabbarkhabeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahtab Barkhabeh
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No4, 6west boostan,35 laleh,Marzdaran blvd,Tehran town
City
Tehran
Province
Tehran
Postal code
1461776195
Phone
+98 21 4426 4451
Email
mahtabbarkhabeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahtab Barkhabeh
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
No4, 6west boostan,35 laleh,marzdaran blvd,Tehran town
City
Tehran
Province
Tehran
Postal code
1461776195
Phone
+98 21 4426 4451
Email
mahtabbarkhabeh@yahoo.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