Comparison of two anesthesia methods, sevoflurane fentanyl and propofol fentanyl, on the severity of cough and laryngospasm in orthopedic surgeries under one hour.
Reduction of complications and death caused by anesthetic drugs
Design
The clinical trial with double-blind, randomized phase 3 is on148 patients. In this study, the samples are randomly selected with the help of a random number table.
Settings and conduct
The patients include 148 participants who are candidates for orthopedic surgery, referring to the orthopedic surgery department of Shahid Mohammadi Hospital, Prophet Azam complex, Bandar Abbas. The patients are under complete cardiac monitoring of oxygen saturation and blood pressure. First, pre-oxygenation with a mask and pre-medication with midazolam (2 mg), fentanyl (2 μg/kg) are performed. Anesthesia induction is performed with propofol (2 mg/kg) and atracurium (0.5 mg/kg). After 3 to minutes, ventilation is done with an LMA mask based on weight. and the variables of the study are measured at the end of the operation after extubation and upon entering the recovery room, after 15 minutes and half an hour after entering the recovery room, and one hour after entering the recovery room. The patients are unaware of the type of drug combination used for anesthesia. they will be. The anesthetist and the one collecting the data are different.
Participants/Inclusion and exclusion criteria
Entry criteria: age 18-75 years old. Exit criteria: not filling out the informed consent form; lack of necessary conditions to receive anesthetic such as heart and kidney diseases; instability of hemodynamic condition and drug abuse.
Intervention groups
In one group, propofol with a dose of 100 micrograms per kilogram of weight per minute and in the other group, sevoflurane with MAC = 2 is used for induction of anesthesia. Patients are under full monitoring of heart, blood pressure and oxygen saturation evaluation.
Comparison of two anesthesia methods, sevoflurane fentanyl and propofol fentanyl, on the severity of cough and laryngospasm in orthopedic surgeries under one hour.
Public title
Comparison of two anesthesia methods, sevoflurane fentanyl and propofol fentanyl, on the severity of cough and laryngospasm in orthopedic surgeries under one hour.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 75
Consent to participate in the study
Exclusion criteria:
Heart and kidney diseases
Hemodynamic instability
Drug abuse
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Generating random numbers from the table of random numbers: Considering that 148 patients are needed in this study, a number was chosen randomly in the table of random numbers and the two digits on the right side of it were taken into account. If these two digits were an even number, the patient was intervention group A, and if there is an individual, they will be assigned to control group B. For example, in the table of random numbers, the number 63 was chosen, since 63 is an odd number, so the first sample will be assigned to the control group. People are divided into two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
In each of the groups, the desired drug is injected into the patient by an anesthesiologist, but the desired information for the research is recorded by an independent researcher who does not know the type of drug and the study group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Hormozgan university of medical sciences
Street address
Shahid moءhammadi hospital, Jomhori Eslami Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Approval date
2022-12-31, 1401/10/10
Ethics committee reference number
IR.HUMS.REC.1401.326
Health conditions studied
1
Description of health condition studied
Respiratory system problem
ICD-10 code
J95.89
ICD-10 code description
Other postprocedural complications and disorders of respiratory system, not elsewhere classified
Primary outcomes
1
Description
Severity of cough
Timepoint
During the operation and after casteob and fifteen minutes later and half an hour and an hour later
Method of measurement
Aldrete score
2
Description
Laryngospasm
Timepoint
During the operation and after casteob and fifteen minutes later and half an hour and an hour later
Method of measurement
Aldrete score
3
Description
Oxygen saturation percentage of arterial blood
Timepoint
During the operation and after casteob and fifteen minutes later and half an hour and an hour later
Method of measurement
Pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 100 mcg per kilogram of body weight will receive propofol for induction of anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group 2: will receive sevoflurane with MAC=2 for anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid mohammadi hospital
Full name of responsible person
Doctor Majid vatankhah
Street address
Shahid mohammadi hospitl street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 933 961 1441
Email
hormozgan91@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Wali Alipour
Street address
Shahid Mohammadi hospital
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 933 961 1441
Email
hormozgan91@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Vice President of Bandar Abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Majid vatankhah
Position
Associate Professor of Bandar Abbas University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahidmohammadi hospital street
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 5224 1819
Email
hormozgan91@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr majid vatan khah
Position
Associate Professor of Bandar Abbas University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahidmohammadi hospital
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 933 091 1441
Email
hormozgan91@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr majid vatankhah
Position
Associate Professor of Bandar Abbas University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahidmohammadi hospital
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 933 961 1441
Email
hormozgan91@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparison of two anesthesia methods, sevoflurane fentanyl and propofol fentanyl, on the severity of cough and laryngospasm in patients who return to the orthopedic surgery department for orthopedic surgery.
When the data will become available and for how long
Up to one year after the publication of the article
To whom data/document is available
Authors and officials of Bandar Abbas University of Medical Sciences
Under which criteria data/document could be used
For use in statistical work and larger studies
From where data/document is obtainable
first author
What processes are involved for a request to access data/document
Send an email to the first author and request the use of the data