In this study we compare two method of anesthesia Propofol and Remifentanil with Isoflorane and N2O. This is a clinical trial on 50 patients with sinus surgery. All surgeries are done by a same surgeon who is blind about the anesthetics drugs. Inclusion criteria include: the patients scheduled for sinus endoscopy and have informed consent and according to American Society of Anesthesiologists have class one and two. Exclusion criteria includes: patients without informed consent, history of high blood pressure, taking blood pressure controllers medicines, anticoagulants, and diabetics. Patients are divided into two groups of anesthesia by Propofol and Isoflurane randomly. Routine monitoring of blood pressure, electrocardiography , deepness of anesthesia and puls oxymetry during surgery is performed. In order to measuring bleeding during surgery, the whole blood in suction container is collected and its hemoglobin is determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202067488N3
Registration date:2012-10-14, 1391/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-14, 1391/07/23
Registrant information
Name
Mohammadali Haghbin
Name of organization / entity
Kerman University of MedicalSciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5814
Email address
m.a.haghbin@gmail.com
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-08-27, 1391/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bleeding between two methods of general anesthesia: propofol-Remifentanil versus isoflurane-N2O in endoscopic sinus surgery
Public title
Bleeding in sinus endoscopy in two methods of anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients that candidate for endoscopic sinus surgery with ASA classification 1 and 2 that signed informed consent
Exclusion criteria : use of anticoagulants or anti-hypertension drugs;any contraindication for use of remifentanil and propofol or other anesthetics; history of diabetes, hypertension; renal or hepatic failure
Age
From 16 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Kerman University of Medical Sciences
Street address
blvd Jomhoori
City
Kerman
Postal code
Approval date
2012-04-03, 1391/01/15
Ethics committee reference number
91.01ک
Health conditions studied
1
Description of health condition studied
Chronic Sinusitis
ICD-10 code
J32.0
ICD-10 code description
Incl.: abscess empyema infection suppuration (chronic) of sinus (accessory)(nasal)
Primary outcomes
1
Description
Blood pressur
Timepoint
per 10 min
Method of measurement
mmhg by electronic monitor
2
Description
Heart Rate
Timepoint
every 10 min
Method of measurement
ECG monitor
3
Description
Deepness of anesthesia
Timepoint
every 10 min
Method of measurement
BIS
Secondary outcomes
1
Description
Bleeding volume
Timepoint
End of surgery
Method of measurement
By measuring hemoglobin and volume of suction cantainer