A comparative study on the effect of fentanyl, morphine and methadone on hemodynamics of patients undergoing laryngoscopy and intubation in chronic users taking drugs by inhaler
A comparative study on the effect of fentanyl, morphine and methadone on hemodynamics of patients undergoing laryngoscopy and intubation in chronic users taking drugs by inhaler
Design
this is a one-blinded clinical trial. The study population will be included all patients refer to Imam Reza hospital of Kermanshah city. A total of .... eligible patients will be selected conveniently and randomly will be assigned in 3 intervention groups.
Settings and conduct
This study, which will be conducted at Imam Reza hospital of Kermanshah city is one-blinded one that the participants will not know what medicine they will receive. patients will be kept blinded to the study groups, does of the medicine and pharmaceutical manufacturer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients taking drugs by inhaler; Under 65 years old
Exclusion criteria: History of heart disease; History of high blood pressure, diabetes and other systemic diseases; Patients who take drugs orally
Intervention groups
The first intervention group will receive intravenous 0.6 mg fentanyl. The second intervention group will receive intravenous 0.6 mg Methadone. The third intervention group will receive intravenous 0.6 mg Morphine. After 2 minutes oxygenation with 100% oxygen, all patients undergo laryngoscopy with Macintosh curved blades 4 or 5 and the intubation will be fitted with a Cuffed tube for oral intubation
Main outcome variables
blood pressure, Pulse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100101002946N10
Registration date:2018-10-28, 1397/08/06
Registration timing:prospective
Last update:2018-10-28, 1397/08/06
Update count:0
Registration date
2018-10-28, 1397/08/06
Registrant information
Name
Mitra Yari
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
myari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of fentanyl, morphine and methadone on hemodynamics of patients undergoing laryngoscopy and intubation in chronic users taking drugs by inhaler
Public title
A comparative study on the effect of fentanyl, morphine and methadone on hemodynamics of patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients taking drugs by inhaler
Under 65 years old
Exclusion criteria:
History of heart disease
History of high blood pressure, diabetes and other systemic diseases
Patients who take drugs orally
Age
To 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients were blinded to the dosage of the drug and the manufacturer of the drug in comparison to the study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-10-10, 1397/07/18
Ethics committee reference number
ir.kums.rec.1397.563
Health conditions studied
1
Description of health condition studied
Tracheal intubation
ICD-10 code
Y84.8
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
blood pressure
Timepoint
Immediately and 5 minutes after laryngoscopy and intubation
Method of measurement
Using the pressure gauge
2
Description
Pulse
Timepoint
Immediately and 5 minutes after laryngoscopy and intubation
Method of measurement
Using Holter Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive intravenous 0.6 mg fentanyl. After 2 minutes oxygenation with 100% oxygen, patients undergo laryngoscopy with Macintosh curved blades 4 or 5 and the intubation will be fitted with a Cuffed tube for oral intubation
Category
Treatment - Drugs
2
Description
The second intervention group will receive intravenous 0.6 mg Methadone. After 2 minutes oxygenation with 100% oxygen, patients undergo laryngoscopy with Macintosh curved blades 4 or 5 and the intubation will be fitted with a Cuffed tube for oral intubation
Category
Treatment - Drugs
3
Description
The third intervention group will receive intravenous 0.6 mg Morphine. After 2 minutes oxygenation with 100% oxygen, patients undergo laryngoscopy with Macintosh curved blades 4 or 5 and the intubation will be fitted with a Cuffed tube for oral intubation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Majid Mosadegh
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6309
Email
majidmosadegh4@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Majid Mosadegh
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6309
Email
majidmosadegh4@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mitra Yari
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
myari@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Majid Mosadegh
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
majidmosadegh4@gmail.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
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail