1) Objectives: This research was accomplished with the purpose of effect of different opioids on traumatic patients' hemodynamic at rapid sequence intubation. 2) Design: 90 traumatic patients aged 18-65 with ASA class I-II who need rapid sequence intubation at emergency department. 3) Setting and conduct: Patients are divided in three groups randomly. Prior to intubation, patients will undergo cardiac monitoring using SAADAT instrument. Heart rate and arterial oxygen saturation will be checked using the same instrument. End-tidal CO2, cardiac output and cardiac index will be measured using NICO instrument. Five minutes after register these data intubation will be done and 3, 5 and 10 minutes after intubation the monitoring data will also be registered. 4) Participants including major eligibility criteria: inclusion criteria: all traumatic patients with normal blood pressure and require intubation. Exclusion criteria include crash intubation. 5) Intervention: Type of used opioids in three group are different. In group one fentanyl, group two alfentanil and group three sufentanil are used as opioid. 6) Main outcome measures variables: The changes observed in these variables will be compared between three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101011067N1
Registration date:2013-05-12, 1392/02/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-12, 1392/02/22
Registrant information
Name
Mahboub Pouraghaei
Name of organization / entity
Tabriz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2078
Email address
pouraghaeim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Effect of Fentanyl, Sufentanil and Alfentanil on Hemodynamic at Rapid Sequence Intubation in the Emergency Department
Public title
comparison of three drugs to prevent hemodynamic response of orothracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include all traumatic patients with normal blood pressure that require intubation in the Emergency Department of Imam Reza (AS) Medical Research and Training Hospital.
Exclusion criteria:Crush intubation, Asthma, Chronic Obstructive Pulmonary Disease, Porphyry, Allergy to lidocaine,difficult intubation based on physician's clinical judgment.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was performed by providing the intubating physician, without informing him about the name of the medication, the different opiates labeled 1, 2 and 3 which were placed in the syringes containing similar amount of medication in each milliliter. When the patient entered the room, a ball was drawn from a bag containing 90 balls (30 balls labeled as 1, 30 as 2 and 30 as 3). Later, based on the number of the ball, the syringe with the similar number was used for the patient throughout the intubation. Neither the patient nor the physician was aware of the name of the opiate used in the intubation as the syringes were placed on the intubation tray by the project executor.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2011-06-12, 1390/03/22
Ethics committee reference number
5/4/2705
Health conditions studied
1
Description of health condition studied
accidents
ICD-10 code
V01-X59
ICD-10 code description
Accidents
Primary outcomes
1
Description
Heart Rate
Timepoint
5 minute before intubation, 3 minute after intubation, 5 minute after intubation, 10 minute after intubation and
Intervention group 1: 30 accidental patients with normal blood pressure that will require intubation with rapid sequence method, alfentanil, single dose intravenous administration 20 micrograms per kilogram (1 cc :500micrograms, Janssen Pharmaceutical Company, Beerse, Belgium) has been used for intubation.
Category
Treatment - Drugs
2
Description
Intervention group 1: 30 accidental patients with normal blood pressure that will require intubation with rapid sequence method, sufentanil, single dose intravenous administration 0.2 micrograms per kilogram (1 cc :5 micrograms, Mylan Pharmaceutical Company, Saint Priest, France) has been used for intubation.
Category
Treatment - Drugs
3
Description
Control group: 30 accidental patients with normal blood pressure that will require intubation with rapid sequence method, fentanyl, single dose intravenous administration 2 micrograms per kilogram (1 cc :50 micrograms, Mylan Pharmaceutical Company, Saint Priest, France) has been used for intubation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (AS) Medical Research and Training Hospital, Tabriz
Full name of responsible person
Mahboob Pouraghaei
Street address
Golgasht Street, Imam Reza (AS) Medical Research and Training Hospital, Emergency Department
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-Chancellor of Tabriz University of Medical Sciences
Full name of responsible person
Seyed Kazem Shakouri
Street address
Golgasht Street, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-Chancellor of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahboob Pouraghaei
Position
Assistant Professor / Emergency Medicine Specialist
Other areas of specialty/work
Street address
Golgasht Street, Imam Reza (AS) Medical Research and Training Hospital, Emergency Department
City
Tabriz
Postal code
Phone
+98 41 1335 2078
Fax
+98 41 1335 2078
Email
pouraghaeim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahboob Pouraghaei
Position
Assistant Professor / Emergency Medicine Specialist
Other areas of specialty/work
Street address
Golgasht Street, Imam Reza (AS) Medical Research and Training Hospital, Emergency Department
City
Tabriz
Postal code
Phone
+98 41 1335 2078
Fax
+98 41 1335 2078
Email
pouraghaeim@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)