The purpose of this study is Comparison of general anesthesia with isoflurane/N2O and propofol/alfentanil on optimal extubation in mandibular fractures with arch bar.
Therefore, 60 patients with mandibular fracture with arch bar with age more than 15years old and ASA I that have not history of hypertension or use of anti hypertensive drug or frequent use of narcotic drug were divided into two groups.In the first group used of combination propofol / alfentanil and in the second group used of combination of isoflurane / N2O for maintenance of anesthesia and finally, hemodynamic status, nausea and vomiting and the patient's condition in terms of comfort during extubation was been evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072412642N16
Registration date:2015-08-13, 1394/05/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-13, 1394/05/22
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Qazvin University of Medical Sciences
Expected recruitment start date
2014-11-30, 1393/09/09
Expected recruitment end date
2015-05-31, 1394/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of general anesthesia with isoflurane/N2O and propofol/alfentanil on optimal extubation in mandibular fractures with arch bar
Public title
Effect of General anesthesia on optimal extubation in mandibular fractures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Patient with ASA I; Age more than 15 years old.
Exclusion Criteria: Patient with history of use of narcotic; Patient with history of use of anti hypertension drug; Patients with hypertension; Patient with age more than 50 years old.
Age
From 15 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
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
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulvar
City
Qazvin
Postal code
Approval date
2013-04-22, 1392/02/02
Ethics committee reference number
28/20/7239
Health conditions studied
1
Description of health condition studied
mandible fracture surgery
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible
Primary outcomes
1
Description
Blood Pressure
Timepoint
From 5 minutes before induction to 15 minutes after induction with 5 minute intervals.
Method of measurement
By mercury sphygmomanometer in mmHg
2
Description
Heart rate
Timepoint
From 5 minutes before induction to 15 minutes after induction with 5 minute intervals.
Method of measurement
By pulse oximetry in terms of number of minutes.
3
Description
Comfort during extubation
Timepoint
From 5 minutes before induction to 15 minutes after induction with 5 minute intervals.
Method of measurement
According scored based on the elevation of the arm or leg and pressing hand of doctor
Secondary outcomes
1
Description
Nausea
Timepoint
From 5 minutes before anesthesia to 24 hours after surgery
Method of measurement
According to the saying patient
2
Description
Vomitting
Timepoint
From 5 minutes before anesthesia to 24 hours after surgery
Method of measurement
According to the saying patient
Intervention groups
1
Description
In the first group after the induction maintenance of anesthesia will done in combination with a dose of 100 micrograms per kilogram body weight in minute propofol and one micrograms per kilogram body weight in minute alfentanyl.
Category
Treatment - Drugs
2
Description
In the first group after the induction maintenance of anesthesia will done in combination with 1%isoflurane and 50/50 mix oxygen and nitrous oxide
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee hospital in Qazvin
Full name of responsible person
Majid Golestani Eraghi
Street address
Padegan Ave
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Taghi Naserpoor Farivar
Street address
Shahid Bahonar Boulvar
City
Qazvin
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 of Qazvin 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
Department of Anesthesiology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Jahangiri Fard
Position
Fellowship of Cardiac Anesthesia
Other areas of specialty/work
Street address
Daneshjoo Ave, Velenjak
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
alirezajahangiri@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesia group, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship specialty intensive care
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)