Various maneuvers are used to achieve the ideal operative field necessary for successful endoscopic sinus surgery and decreased complications. controlled hypotension is one way that used to improve surgical conditions during endoscopic sinus surgery (mean arterial pressure 60-70mmHg)
short acting anesthetics such as propfol and remifentanil allow control of intraoperative deliberated hypotension and thus might be valuable tools to compare with (traditional) balances anesthesia. The aim of this study is to compare the surgical field in patients in whom intravenous anesthesia is used as apposed to balanced general anesthesia. For this reason in a patient-observer blind randomized clinical trial 44 patients from 15 to 45 years old that scheduled for endoscopic sinus surgery will select (after explaining the process of the trial, written informed consent obtained from participants). Then they will divide into two groups randomly, for the first group total intravenous anesthesia propofol 50mic/ kg/min+ remifentanil 0.1 mic/kg/min), second group (Isofluran 0.6%) and surgical condition and intraoperative bleeding will be recorded and then analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102081138N7
Registration date:2011-03-14, 1389/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-03-14, 1389/12/23
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2010-06-13, 1389/03/23
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of surgical condition and bleeding during propofol or isofluran anesthesia for endoscopic sinus injury
Public title
Comparison of propofol or isofluran anesthesia for sinus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidated for elective endoscopic sinus surgery (15-45yr); ASA class I,II; Patients with completely treated nose and sinus infections
Exclusion criteria:
History of hemorrhagic disease; Seizure; Drugs that affect on the surgical homeostasis; Anemia (Hb <10); Poor controlled cerebrovascular accident; History of significant CAD; Arrhythmia; Liver or kidney dysfunction; Electrolyte or metabolic abnormalities; COPD; Severe asthma or other severe respiratory disease; History of PUD; Pregnancy
Age
From 15 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
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 Guilan University of Medical Sciences
Street address
Siadati st.
City
Rasht
Postal code
Approval date
2010-06-12, 1389/03/22
Ethics committee reference number
572
Health conditions studied
1
Description of health condition studied
Chronic Sinusitis
ICD-10 code
J32.9
ICD-10 code description
Chronic sinusitis, unspecified
Primary outcomes
1
Description
Surgical field condition
Timepoint
Every 15 minutes
Method of measurement
With table
Secondary outcomes
1
Description
Intraoperative bleeding percent
Timepoint
Every 15 minutes Intraoperatively
Method of measurement
Maximum allowable blood loss formula
Intervention groups
1
Description
Group A) propofol (50/mg/kg/min) + remifentanyl (0/1 mg/kg/min) group
Category
Treatment - Drugs
2
Description
Group B) Insofluran group
(0-0/6%)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Sudabeh Haddadi
Street address
17 Shahrivar st.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Susan Komaii
Street address
Siadati st.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences, Vice Chancellor for Research
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
Guilan University of Medical Sciences
Full name of responsible person
Dr Sudabeh Haddadi
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 Shahriva st.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
So_haddadi@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Sudabeh Haddadi
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 Shahrivar st.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
So_haddadi@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)