The aim of this study is to compare the effects of two widely used narcotics ( remifentanil and alfentanil ) in general anesthesia
Methods: Sixty female patients , aged 18- 35, scheduled for elective otolaryngologic operations under general anesthesia with American Society of Anesthesiologists physical status I (ASA I) without any heart disease ( arrhythmia , valvular ), were randomly allocated to two groups. In both groups bolus dose of remifentanil and alfentanil were followed by infusion of the same drugs . Anesthesia was induced with propofol , muscle relaxation facilitated by cisatracurium .ECG (Three lead electrocardiogram), heart rate and non-invasive blood pressures were recorded at the following times: before and 90 seconds after the induction of anesthesia, 1 min. and 5 min. after endotracheal intubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210172310N2
Registration date:2014-01-20, 1392/10/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-20, 1392/10/30
Registrant information
Name
MANSOOR MASJEDI
Name of organization / entity
SHIRAZ UNIVERSITY OF MEDICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 1562
Email address
masjedi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences ( SUMS ) -This study has received research grant from Vice-Chancellery of Research and Technology of Shiraz University of medical sciences ( grant No. CT-87-4291) .
Expected recruitment start date
2008-06-03, 1387/03/14
Expected recruitment end date
2011-06-06, 1390/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Remifentanil and Alfentanil on QT interval in elective surgery under general anaesthesia
Public title
Effect of opioids on heart under general anaesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-35 years; ASA - PS ( American Society of Anesthesiologist- Physical Status) : I ; Elective ENT ( Ear-Nose-Throat ) operation under general anesthesia.
Exclusion criteria : Abnormal serum electrolytes, cardiovascular or psychiatric problems; idiopathic or acquired prolonged QT interval;anticipated difficulty in tracheal intubation ; patients taking any medication affecting QTc interval ( e.g. :tricylic antidepressant ,antidysrhythmics, β-adrenergic antagonists, calcium channel blockers); existence of cardiac valvular disease; any cardiac rhythm abnormality; diabetes mellitus ; pregnancy ; obesity ( body mass index > 30 ) and hypersensitivity reaction to egg, fish or soya bean .
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Shiraz University of Medical Sciences- Ethics Committee
Street address
Zand street
City
shiraz
Postal code
Approval date
2011-03-28, 1390/01/08
Ethics committee reference number
CT-87-4291
Health conditions studied
1
Description of health condition studied
conduction disorder
ICD-10 code
145.8
ICD-10 code description
Other specified conduction disorders
2
Description of health condition studied
General anesthesia
ICD-10 code
146.9
ICD-10 code description
Cardiac arrest, unspecified
Primary outcomes
1
Description
QT interval
Timepoint
Before and 90 seconds after induction of anesthesia, 1 and 5 minutes after endotracheal intubation
Method of measurement
Electrocardiograph
Secondary outcomes
1
Description
Heart rate
Timepoint
Before and 90 seconds after induction of anesthesia, 1 and 5 minutes after endotracheal intubation
Method of measurement
Operating room monitor
2
Description
Blood pressure
Timepoint
Before and 90 seconds after induction of anesthesia, 1 and 5 minutes after endotracheal intubation
Method of measurement
Operating room monitor
Intervention groups
1
Description
In one group , as anesthetic premedication , bolus dose of intravenous remifentanil (2 μg / kg over 60 seconds) will be given followed by its infusion ( 0.15 μg / kg / min ) throught maintenance of anesthesia . In all patients , anesthesia will be induced by propofol ( 2 mg / kg ) and muscle relaxation by cisatracurium ( 0.1 mg / kg )
Category
Prevention
2
Description
In the other group , as anesthetic premedication , bolus dose of alfentanil ( 20 μg / kg over 60 seconds ) will be followed by its infusion ( 0.25 μg / kg / min )throught maintenance of anesthesia . Anesthesia will be induced with propofol ( 2.5 mg / kg ) and muscle relaxation facilitated by cisatracurium ( 0.1 mg/kg )
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University affiliated hospitals
Full name of responsible person
Mansoor Masjedi
Street address
No. 603,5 th avenue , Khalili street , Mollasadra street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Street address
Zand st, Central building of the University
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz Anesthesiology and Critical Care Research Center, Department Of Anesthesia, Medical school ,
Full name of responsible person
Mansoor Masjedi,
Position
MD,FCCM ( Fellowship of critical care medicine)
Other areas of specialty/work
Street address
No. 603,5 th avenue , Khalili street , Mollasadra street
City
Shiraz
Postal code
71936/34153
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
masjedi@sums.ac.ir , mansoormasjedi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences ( SUMS )
Full name of responsible person
Mohammad Hosein Eghbal
Position
MD , Fellowship of anesthesia for organ transplant