Comparison of the effect of Pofoll, Isoflurane and Nitric oxide on endotracheal tube cuff pressure in patients undergoing elective surgery with general anesthesia
The aim of this study is to evaluate changes of tracheal tube cuff pressure in elective surgeries and prevention from complications of high or Low cuff pressure. All of 18 to 65 years old patients undergoing elective surgery that do not have head, neck and thorax surgery and their surgery last more than 90min under general anesthesia with tracheal intubation will be evaluated. 134 patients will be randomly assigned to 4 groups Pofoll, Propofol, Isoflurane and Nitric oxide, and the cuff pressure will be checked after intubation and every 30 minutes
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090412642N4
Registration date:2014-10-04, 1393/07/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-04, 1393/07/12
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 Arak University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Pofoll, Isoflurane and Nitric oxide on endotracheal tube cuff pressure in patients undergoing elective surgery with general anesthesia
Public title
The effect of anesthetic agents on tracheal tube cuff pressure
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: Patients undergoing elective surgery; ASA class I and II
exclusion criteria: Patients outside the age range 15 to 65 years; patients with a high ASA class II; patients with systemic disease heart- lung, renal endocrine or metabolic; morbid obesity (BMI>40); Surgical practice time for less than 1.5 hour; positions other than supine; head and neck and thoracic surgery; neck rotation during surgery more than 10 degrees; Endotracheal tube cuff pressure increases to more than 40 cmH2o during anesthesia; difficult intubation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
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
Research Ethics Committee of Arak University of Medical Sciences
Street address
Ethical committee of Research of Arak University of Medical Sciences, Sardasht Square,Arak
City
Arak
Postal code
Approval date
2014-06-16, 1393/03/26
Ethics committee reference number
93-164-1
Health conditions studied
1
Description of health condition studied
tracheal intubation
ICD-10 code
T88.7
ICD-10 code description
Unspecified adverse effect of drug or medicament
Primary outcomes
1
Description
tracheal cuff pressure
Timepoint
Before the experiment and then every 30 minutes
Method of measurement
In millimeters of mercury using a cuff pressure manometer
Secondary outcomes
1
Description
blood pressure
Timepoint
end of study
Method of measurement
Manometer to measure the pressure
2
Description
heart rate
Timepoint
end of study
Method of measurement
with pulse oxymetry
Intervention groups
1
Description
(group A) use of intravenous hypnotic anesthetic (propofol) with dosage of 150ug/kg/min have received in during general anesthesia
Category
Early detection
2
Description
(group B) use of volatile anesthetic (isofluranl) 1% in during general anesthesia
Category
Early detection
3
Description
(group C) use of Patients in the intravenous hypnotic anesthetic (propofol) with dosage of 150ug/kg/min with N2o ratio 50-50 in general anesthesia
Category
Early detection
4
Description
(group D) use of volatile anesthtic(isofluran) 1% with N2O ratio 50-50in general anesthesia
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Majid Golestai Eraghi
Street address
Valiasr square
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research of Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Rafiee
Street address
Vice Chancellor of Research of Arak University of Medical Sciences, Sardasht Square, Arak,
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr hospital, valiasr square, Arak
City
Arak
Postal code
Phone
+98 86 3222 2003
Fax
Email
dr.golestani@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Science
Full name of responsible person
Majid Golestani Eraghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Square
City
Arak
Postal code
Phone
+98 86 3222 2003
Fax
Email
dr.golestani@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)