Comparing the effect of fentanyl, sufentanil and alfentanil on cardiovascular response after tracheal intubation in opiate addicted patients after elective surgeries.
According to our knowledge addicted patients are resistant to analgesic effects of opioids,thus the aim of this study was to clarify which of opioids that routinely used in anesthesia could reduce the cardiovascular response to intubation. In this randomized double blind study 93 patients who were scheduled for elective surgery under general anesthesia, allocated in three groups according to the type of opioid administered for them to induce anesthesia, alfentanil 20 µg/kg, sufentanil 0.2 µg/kg, fentanyl 2 µg/kg. Regardless of the type of the opioid propofol 20 mg/kg, atracurium 0.5 mg/kg and midazolam 1-2 mg were administered in all 3 groups. Non-Invasive blood pressure and heart rate was measured before induction of anesthesia, 3 minutes after it and immediately after tracheal intubation. Systolic, diastolic, mean blood pressure and heart rate at each of aforementioned times was compared between three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011721383N4
Registration date:2016-03-13, 1394/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-13, 1394/12/23
Registrant information
Name
Amir Saber Tanha
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 2778
Email address
dr.saber@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences.
Expected recruitment start date
2016-01-13, 1394/10/23
Expected recruitment end date
2016-09-13, 1395/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of fentanyl, sufentanil and alfentanil on cardiovascular response after tracheal intubation in opiate addicted patients after elective surgeries.
Public title
Comparing the effect of fentanyl, sufentanil and alfentanil on hemodynamic changes after tracheal intubation in opiate addicted patients.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all opiate addicted patients who were scheduled to undergo elective surgeries with tracheal intubation.
Exclusion criteria: hypertension; non elective surgeries; diabetes mellitus; dysautonomia; heart failure; severe hemorrhage; severe hemodynamic instability.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand, Iran.
City
Birjand
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2016-01-11, 1394/10/21
Ethics committee reference number
Ir.bums.1394.85
Health conditions studied
1
Description of health condition studied
Cardiovascular response
ICD-10 code
B57.0
ICD-10 code description
Acute Chagas disease with heart involvement
Primary outcomes
1
Description
Blood pressure
Timepoint
Before induction of anesthesia, 3 minutes after induction of anesthesia, after intubation
Method of measurement
In mmhg with digital manometer
2
Description
Heart rate
Timepoint
Before induction of anesthesia, 3 minutes after induction of anesthesia, after intubation
Method of measurement
Beat per minute with electrocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Administration of alfentanil 20 microgram per kilogram of body weight before induction of anesthesia.
Category
Prevention
2
Description
Administration of fentanyle 2 microgram per kilogram of body weight before induction of anesthesia.
Category
Prevention
3
Description
Administration of sufentanil 0.2 microgram per kilogram of body weight before induction of anesthesia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital of Birjand University of Medical Sciences.
Full name of responsible person
Dr. Amir Saber Tanha
Street address
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Asghar Zarban
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand, Iran
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assisstant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand.
City
Birjand
Postal code
Phone
+98 56 3243 2778
Fax
Email
amirsaber63@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand
City
Birjand
Postal code
Phone
+98 56 3243 2778
Fax
Email
amirsaber63@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand
City
Birjand
Postal code
Phone
+98 56 3243 2778
Fax
Email
amirsaber63@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)