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Comparison of the Effect of Alfentanil and Remifentanil on QT Interval in Septoplasty with Local Epinephrine

Protocol summary

Summary
Objectives: To compare the effects of remifentanil and alfentanil on the corrected QT interval in Septoplasty surgery under general anesthesia followed by local injection of epinephrine. ECG QT interval was recorded at specific time intervals in patients who are admitted to Dastghib hospital(referral center in Shiraz,southern Iran) for Septoplastysurgeryundergeneral anesthesia, and local injection of epinephrine. Method: 84 patients were randomly divided into two groups. Patients in treatment group received short acting narcotics (remifentanil and alfentanil) while,ECG QT interval recordedatspecific time intervals. Inclusion criteriaincludedpatientsaged18-50 years who are classified as ASA I-II (America Society of Anesthesiologists) under general anesthesia for septoplasty and local injection of epinephrine are enrolled the study. Patients were excluded from the study if any of the following criteria were present:Use of any drug affecting QT interval in last 14 days including: tricyclic antidepressants (TCAs), anti-arrhythmic drugs,β blockers and calcium channel blockers, idiopathic or acquired QTc prolongation in preoperative electro cardiogram(ECG)( QTc >440 ms), existence of arrhythmia (e.g. bundle branch block, preexcitation syndrome or AV nodal arrhythmia), structural heart disease, electrolyte disturbance, hypo or hyperthyroidism, obesity with BMI >30, diabetic neuropathy , any rhythm besides sinus rhythm in baseline ECG, allergy to propofol ,egg and soya bean, need to use of β blockers or volatiles for controlling of excessive bleeding.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014020816524N1
Registration date: 2014-11-30, 1393/09/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-30, 1393/09/09
Registrant information
Name
Fatemeh Tubaei
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3623 2876
Email address
toobaief@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Alfentanil and Remifentanil on QT Interval in Septoplasty with Local Epinephrine
Public title
Effect of Alfentanil and Remifentanil on QT Interval
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with physical status class I -II, based on the classification of the American Society of Anesthesiologists (ASA) and the age up to50 years undergoing septoplasty. Exclusion criteria: the use of any effective drug on QT interval in 14 days before surgery (TCA); beta antagonist, anti-arrhythmic, the calcium channel blocker) ; QTc more than 440 m/s; The existence of branches blocks, arrhythmia (preexitation syndrome) ; Structural heart disease.; electrolyte imbalance; hyper or hypothyroid patients 7. Extreme Obesity BMI 30 >; Diabetic neuropathy; Any non- sinus rhythm in EKG; A history of sensitivity to propofol, egg and soy.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University Of Medical Sciences , Zand street
City
Shiraz
Postal code
Approval date
2013-10-08, 1392/07/16
Ethics committee reference number
cp-p-92-6118

Health conditions studied

1

Description of health condition studied
QT Prolongation
ICD-10 code
R 94.3
ICD-10 code description
Electrocardiogram [ECG][EKG]

Primary outcomes

1

Description
QT interval
Timepoint
Prioperative /Six times
Method of measurement
EKG

Secondary outcomes

1

Description
Heart Rate Monitoring
Timepoint
Six Times Perioperative
Method of measurement
EKG

Intervention groups

1

Description
In intervention group we use alfentanil 20-25 microgram/kg in induction and with rate of 0.5-2 microgram/kg/min in maintenance .In control group remifentanil is use with dose of 1-2 microgram/kg in induction and infused with rate of 0.2-0.25 microgram/kg/min in maintenance of anesthesia.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Fatemeh Toobaei
Street address
Hafezieh Square, next to Bagh Melli
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, 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 University of Medical Sciences
Full name of responsible person
Fatemeh Toobaei
Position
Physician, Anesthesiology resident
Other areas of specialty/work
Street address
Anesthesiology Office, Shahid Faghihi HospitaL, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3233 7636
Fax
Email
toobaeif@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Mansoor Masjedi
Position
Anesthesilogist, Intensive Fellowship
Other areas of specialty/work
Street address
Anesthesiology office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 713647427000
Fax
Email
masjedi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Fatemeh Toobaei
Position
Anesthesilogy resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3233 7636
Fax
Email
toobaief@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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