Comparison the effects of general anesthesia with isoflurane-nitrous oxide versus propofol-alfentanil on the desirable condition of extubation of patients with arch bar in mandibular fracture surgery
The aim of this study was comparison the effects of anesthesia with isoflurane-N2O versus propofol-alfentanyl on the desirable extubation condition of patients with arch bar in mandibular fracture surgery.
In this randomized double blinded clinical trial study, sixty patients who scheduled for fixing of mandibular fracture with arch bar had been studied. Inclusion criteria were age 15-50 years old; ASA class I; presence of mandibular fracture and patient consent. Exclusion criteria of the study were consumption of narcotic; sedative or antihypertensive drugs and the presence of sensitivity to drugs used in this study such as propofol or narcotics.
The patients were divided randomly in two groups. Drugs used for premedication and induction of general anesthesia were the same in the two groups. For maintenance of general anesthesia, one group received propofol (100 μg/kg/min) with alfentanil (1 μg/kg/min) but patients in the other group received isoflurane 1.2% (1 MAC) with N2O-O2 (50%-50%). Optimal condition for extubation was evaluated by the presence of bucking, patients' cooperation for eye opening, head elevation, legs elevation and hand grasping for five seconds. Finally in the presence of above conditions, patients were extubated. Blood pressure and heart rate of the patients were measured every five minutes from five minutes before induction of anesthesia until fifteen minutes after extubation. After extubation, incidence of nausea and vomiting were determined and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201405037695N4
Registration date:2014-06-04, 1393/03/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-04, 1393/03/14
Registrant information
Name
Seyedeh Masoumeh Hosseini Valami
Name of organization / entity
Qazvin University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1334 8419
Email address
smhosseiniv@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of general anesthesia with isoflurane-nitrous oxide versus propofol-alfentanil on the desirable condition of extubation of patients with arch bar in mandibular fracture surgery
Public title
Comparison the effects of general anesthesia with isoflurane-nitrous oxide versus propofol-alfentanil on desirable condition of extubation of patients with arch bar in mandibular fracture surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: mandibular fracture surgery with arch bar; age 15-50 years old; ASA class I; patients' consent
Exclusion criteria: consumption of narcotic; sedative or antihypertensive drugs; presence of hypertension or impairment of consciousness; sensitivity to isoflurane, nitrous oxide, propofol and alfentanil
Age
From 15 years old to 50 years old
Gender
Both
Phase
2-3
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
Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blv, Qazvin
City
Qazvin
Postal code
3419759811
Approval date
2011-12-26, 1390/10/05
Ethics committee reference number
28/20/7239
Health conditions studied
1
Description of health condition studied
Mandibular fracture
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible
Primary outcomes
1
Description
Desirable condition for endotrcheal extuation
Timepoint
After endotrcheal etubation in operating room
Method of measurement
By the presence of bucking, patients' cooperation for eye opening, head elevation , legs elevation and hand grasping for five seconds
Secondary outcomes
1
Description
Blood pressure and heart rate
Timepoint
Every five minutes from five minutes before induction of anesthesia until fifteen minutes after extubation
Method of measurement
By noninvasive blood pressure and cardiovascular monitoring
2
Description
Nausea, vomiting
Timepoint
After endotracheal extubation and in recovery room
Method of measurement
Visual
Intervention groups
1
Description
Patients in one group received propofol (100 μg/kg/min) with alfentanil (1 μg/kg/min).
Category
Treatment - Drugs
2
Description
Patients in another group received isoflurane 1.2% (1 MAC) with N2O-O2 (50%-50%). We did not have any control group in this study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaee Hospital
Full name of responsible person
Dr. Seyed Abbas Hosseini Jahromi
Street address
Shaheed Rajaee Hospital, Padegan street
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research Qazvin University of Medical Sciences
Full name of responsible person
Dr. Saeid Asefzadeh
Street address
Qazvin University of Medical Sciences, Shahid Bahonar street
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 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
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Masoumeh Hosseini Valami
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shaheed Bahonar Street
City
Qazvin
Postal code
Phone
+98 281336001
Fax
Email
smhosseiniv@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Abbas Hosseini Jahromi
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shaheed Bahonar street
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
Email
sahosseinij@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Abbas Hosseini Jahromi
Position
Anesthesiologist, Associate Professor
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shaheed Bahonar street
City
Qazvin
Postal code
Phone
+98 28 1333 6001
Fax
Email
sahosseinij@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)