This study is a prospective and randomized double-blind clinical trial. The aim of this study is effect of isoflurane on bleeding and hemodynamic changes in patients under going endoscopic sinus surgery. Total of sample size is 90 patient with ages: 18-50 years old. Inclusion criteria are patients candidate for sinus surgery. The patients with heart disease, liver disease, drug allergy to isoflurane gas will be excluded. Patients are randomly divided into three groups with table of random numbers by computer. Assessor of study and patients do not know about type of drug and grouping people. Anesthesia induction in three groups is with with 0.05 mg/kg midazolam, 2 mcg/kg fentanyl, 5 mg thiopental sodium and 0.5 mg/kg atracurium. All three groups receives 0.1 mcg/kg/min remifentanil infusion. Maintenance of anesthesia in the first group is 0.8 MAC of isoflurane. Maintenance of anesthesia in the second group is 1 MAC of isoflurane. Maintenance of anesthesia in the third group is 1.2 MAC of isoflurane. Patients basic information such as age and sex, BMI will be recorded in all three groups before intervention and after the end of intervention period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011526025N1
Registration date:2016-02-04, 1394/11/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-04, 1394/11/15
Registrant information
Name
Artadokht Khoshooei
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2922
Email address
khoshooei.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2015-10-18, 1394/07/26
Expected recruitment end date
2016-03-17, 1394/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of isoflurane on bleeding and hemodynamic changes in patiants undergoing endoscopic sinus surgery
Public title
the effect of Isoflurane anesthesia gas on blood circulation and bleeding in patients undergoing surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Patients candidate for sinus surgery; ASA (American society of anesthesiology) physical class one and two; Patient with ages: 18-50 years old. Exclusion Criteria: History of kidney problems; Heart disease; Liver disease; Drug allergy to isoflurane; Lack of patient satisfaction.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University Of Medical Sciences
Street address
Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan BLvd., Ahvaz
City
Ahvaz
Postal code
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.AJUMS.REC.1394.395
Health conditions studied
1
Description of health condition studied
Intraoperative bleeding
ICD-10 code
Y60
ICD-10 code description
Unintentional cut, puncture, perforation or haemorrhage during surgical and medical care
Primary outcomes
1
Description
Body mass index (BMI)
Timepoint
Before the start of surgery
Method of measurement
Using the formula: weight (kg) / the square of the height (m)
2
Description
The amount of hemoglobin
Timepoint
Immediately before surgery and immediately after surgery and 6 hours after surgery
Method of measurement
Venous sampling and sent to the laboratory
3
Description
The amount of hematocrit
Timepoint
Immediately before surgery and immediately after surgery and 6 hours after surgery
Method of measurement
Venous sampling and sent to the laboratory
4
Description
Bleeding (By calculating the difference between pre- and postoperative hemoglobin(Hb))
Timepoint
After surgery
Method of measurement
Using the formula: CBL= BV×(Hb loss/Hb per), Hb loss = Hb pre – Hb post + t (The number of injected packed red blood cell units)
5
Description
Bleeding (By calculating the difference between pre- and postoperative hematocrit(Hct))
Timepoint
After surgery
Method of measurement
Using the formula: CBL = RBCL / [(HCTper+HCTpost)/2], RBCL = BV × (Hct pre – Hct post) + 320 t
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 2: Prescription 1.2 MAC of isoflurane as a maintenance of anesthesia during surgery.
Category
Prevention
2
Description
Control group: Prescription 0.8 MAC of isoflurane as a maintenance of anesthesia during surgery.
Category
Prevention
3
Description
Intervention group1: Prescription 1 MAC of isoflurane as a maintenance of anesthesia during surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Khomeini Hospital
Full name of responsible person
Ali Ghomeishi
Street address
Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor For Research Of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Vice chancellor For Research Of Ahvaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
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 Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Artadokht Khoshooei
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
Ar_khoshooei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Reza Akhondzadeh
Position
anesthesiologist
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
rezaakh@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd., Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3222 2922
Fax
Email
s.nz1990@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)