Effects of fentanyl versus remifentanyl pretreatment on the QTc interval in patients undergo rapid sequence intubation
Design
Phase 2, randomized, parallel clinical trial. Randomization will be done by using a table of random numbers. Sample size will be 25 samples in each group.
Settings and conduct
Patients who need rapid sequence intubation admited in Imam Reza hospital, Tabriz, will be administered fentanyl and Novocain in control group and remifentanyl and lidocain in intervention group for prophylaxis. Sedation will be inducted by Etomidate and succinylcholine and laringoscopy and intubation will be done. ECG will be obtained prior to prophylaxis drugs injection, one minutes after medication injection and after laryngoscopy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients older than 18 years old who need rapid sequence intubation for airway management. Patients with a history of cardiovascular disease, diabetes mellitus, chronic hypertension, intracranial injury, drug poisoning and chronic medication use will be excluded.
Intervention groups
Control group will be treated by 2 micg/Kg fentanyl and 1.5 Mg/Kg lidocaine five minutes before laryngoscopy. Three minutes after administration, sedation will be induced by 0.2 Mg/Kg etomidate and 1.5 Mg/Kg succinylcholine. Ninety seconds after induction laryngoscopy will be done.
Intervention group will receive same drugs in same times and manner except fentanyl will be replaced by remifentanyl 1micg/Kg.
Main outcome variables
Corrected QT interval in 3 ECGs, longest QT interval, shortest QT interval and QT interval dispersion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090923002496N12
Registration date:2019-05-04, 1398/02/14
Registration timing:registered_while_recruiting
Last update:2019-05-04, 1398/02/14
Update count:0
Registration date
2019-05-04, 1398/02/14
Registrant information
Name
Hassan Soleimanpour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1329 1286
Email address
soleimanpourh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of fentanyl versus remifentanyl pretreatment on the QTc interval in patients undergo rapid sequence intubation
Public title
Effects of fentanyl versus remifentanyl pretreatment on the QTc interval in patients undergo rapid sequence intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients need airway management by rapid sequence intubation/induction
Age over 18 years
Exclusion criteria:
cardiovascular disease
diabetes
chronic hypertension
hypersensitivity to fentanyl or remifentanyl
intracranial injury
drug poisoning
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, subjects will be divided in control and intervention groups individually by using a simple randomization method by table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethic committee of Research Vice chancellor of Tabriz University of Medical Sciences
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
51664
Approval date
2019-02-04, 1397/11/15
Ethics committee reference number
IR.TBZMED.REC.1397.921
Health conditions studied
1
Description of health condition studied
Rapid sequence intubation/induction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
corrected QT interval
Timepoint
Before administration of fentanyl or remifentanyl, 1 minute after administration and after laringoscory
Method of measurement
ECG
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In pretreatment Phase of RSI a single dose of 1 micg/Kg of remifentanyl ( Hamlen- Germany) will be administrated intravenously.
Category
Treatment - Drugs
2
Description
Control group: In pre-treatment phase of RSI a single dose of 2 micg/Kg of fentanyl will be injected intravenously. We will use the fentanyl made by Aburaihan pharmaceutical Co.-Iran.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr.Hassan Soleimanpour
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Jouyban
Street address
Research Vice chancellor of Tabriz University of Medical Sciences ,Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614776
Phone
+98 41 3335 7313
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emergency Medicine Department, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz-51664, I.R IRAN. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2078
Email
soleimanpourh@tbzmed.ac.ir
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
Yes - There is a plan to make this available
Title and more details about the data/document
All collected de identified IPD.
When the data will become available and for how long
Data will be available in september 2020.
To whom data/document is available
Data will be available for all interested researchers.
Under which criteria data/document could be used
Data will be available for use in other studies. researchers can ask for data of this study by sending email to dr. Hassan Soleimanpour.
From where data/document is obtainable
Dr. Hassan Soleinampour
soleimanpourh@tbzmed.ac.ir
What processes are involved for a request to access data/document
In two weeks after sending data request email, they can receive data.