ASA class I-II patients aged 18-60 who need orotracheal intubation for 40 surgical operations requiring general anesthesia will be enrolled in the study and randomly allocated into two groups. Patients with chronic use of opioids or sedatives and probable difficult intubation will be excluded. In the first group(R group) after induction of anesthesia with target controlled infusion of propofol and receiving of BIS to 45-60 remifentanil infusion will be started with target controlled infusion method and 4ng/ml as effect site target concentration. In the second group(S group) sufentanil will be infused instead of remifentanil with 0.2 ng/ml as effect site target concentration. Blood pressure and heart rate will be measured and compared in two groups in 4 different time points.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710011361N3
Registration date:2009-01-12, 1387/10/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-01-12, 1387/10/23
Registrant information
Name
Naser Yeganeh
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
4276309 831 98+
Email address
nyeganeh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pro-vice-chancellor for research of Kermanshah University of Medical Sciences
Expected recruitment start date
2008-12-25, 1387/10/05
Expected recruitment end date
2009-03-30, 1388/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of target-controlled infusion of remifentanil Vs sufentanil in blunting hemodynamic responses of orotracheal intubation.
Public title
Comparison of two drugs to prevent hemodynamic responses of orotracheal intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:18-60 years old, ASA I-II, surgical operations need orotracheal intubation to perform surgery
Exclusion criteria:denial of patients,any dependency to opioids or other sedatives,any predicted difficult intubation
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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
1
Registry name
UMIN(university for medicine and information network)-JAPAN
Secondary trial Id
UMIN000001564
Registration date
2008-12-12, 1387/09/22
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences Ethical Committee
Street address
Shahid Beheshti Bulvard
City
Kermanshah
Postal code
Approval date
2008-08-06, 1387/05/16
Ethics committee reference number
420/2308
Health conditions studied
1
Description of health condition studied
Orotracheal anesthesia
ICD-10 code
Y45.0
ICD-10 code description
complication of medical and surgical care-opioids and related analgesics
Primary outcomes
1
Description
Blood pressure
Timepoint
before anesthesia, one, three and five minutes after intubation
Method of measurement
clinical examination and non invasive blood pressure measurement
2
Description
Heart Rate
Timepoint
Before anesthesia, one, three and five minutes after intubation
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
infusion of remifentanil as analgesic (with TCI) after the patient is anesthetised
Category
empty
2
Description
infusion of sufentanil as analgesic (with TCI) after the patient is anesthetised
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Naser yegane - Mohammad latifi
Street address
Department of Anesthesia and Intensive Care
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pro-vice-chancellor for research,Kermanshah University of Medical Sciences(KUMS)
Full name of responsible person
Dr. H.Khazaie, Pro-vice-chancellor
Street address
Shahid Beheshti Bulvard
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pro-vice-chancellor for research,Kermanshah University of Medical Sciences(KUMS)
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
Imam Reza Hospital
Full name of responsible person
Naser Yeganeh
Position
Anesthesiologist/Assisstant Professor
Other areas of specialty/work
Street address
Departement of Anesthesia and Intensive Care
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
nyeganeh@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam reza hospital
Full name of responsible person
Naser Yeganeh
Position
Anesthesiologist/ Assisstant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
nyeganeh@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iimam Reza Hospital
Full name of responsible person
Naser Yeganeh
Position
Anesthesiologist/Assisstant Professor
Other areas of specialty/work
Street address
Departement of Anesthesia and Intensive Care
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
Email
nyeganeh@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)