Objectives: The aim of this study is to compare the effect of maintenance anesthesia with propofol versus isoflurane on patients' blood loss and hemodynamic during simple laminectomy surgery.
Design: clinical trial phase 3, unicentrinc study, 80 patients sample size, single blind, simple randomization.
Setting and conduct: After assign inform consent, patients are allocated randomly into the propofol (P) and isoflurane (I). Anesthesiology specialist performs Induction and maintenance of anesthesia during surgery.
Participants: patients, candidate for simple lumbar laminectomy surgery with ASA score ≤ 2. Exclusion criteria are either sensitivity to propofol or isoflurane, a history of renal or coagulation disorders.
Intervention: induction of anesthesiology and its maintenance using infusion of propofol (150 micro-grams per patient’s weight (kg) per minutes) in P group, and isoflurane (1-1.5 maximum alveolar concentration (MAC)) in I group, through the whole duration of surgery.
Outcome measures: primary outcome measures include Blood loss through Boezzart criteria; volume of blood in suction bottle; estimated blood on gauzes; comparison of hematocrit and hemoglobin of blood obtained from surgical field; urinary output during surgery.
Secondary outcome measures: mean arterial blood pressure; heart rate; duration of operation; need for blood transfusion.
General information
Acronym
ASA: American Society of Anesthesiology
IRCT registration information
IRCT registration number:IRCT2015070723098N1
Registration date:2015-10-11, 1394/07/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-11, 1394/07/19
Registrant information
Name
Mohammadreza Shaghaghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 1753
Email address
mr-shaqaqi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, AJA University of Medical Sciences
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2016-09-01, 1395/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of general anesthesia using Isoflurane and Propofol for lumbar laminectomy surgery
Public title
Comparison of two methods of intravenous and inhalation anesthesia for spinal disc surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: laminectomy surgery for lumbar disc herniation; ASA score ≤ 2.
exclusion criteria: Allergy to propofol; Allergy to isoflurane; Refuse patient; Coagulation disorders; History of renal disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
simple randomization using pockets
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
AJA University of Medical Sciences, Etemad Zadeh st, Fatemi st,
City
Tehran
Postal code
Approval date
2015-06-15, 1394/03/25
Ethics committee reference number
AJAUMS.REC.1394.15
Health conditions studied
1
Description of health condition studied
Hemorrhage
ICD-10 code
Y60.0
ICD-10 code description
During surgical operation
Primary outcomes
1
Description
Blood on gauzes
Timepoint
End of surgery
Method of measurement
20 milliliter blood for each standard wet gauze. 50 milliliter for each long gauze.
2
Description
Quality of hemorrhage
Timepoint
End of surgery
Method of measurement
Boezzart criteria
3
Description
Blood in suction buttle
Timepoint
End of surgery
Method of measurement
Volume of blood in suction bottle in milliliter
4
Description
Hematocrit of blood in surgical field
Timepoint
During surgery
Method of measurement
Laboratory measurement in percent
5
Description
Urine output
Timepoint
End of surgery
Method of measurement
Volume of liquid in urine bag in Milliliter
Secondary outcomes
1
Description
Heart rate
Timepoint
15 minutes after anesthesia induction
Method of measurement
Electrocardiogram monitoring (beats per minute)
2
Description
Mean arterial blood pressure
Timepoint
15 minutes after anesthesia induction
Method of measurement
Automatic noninvasive blood pressure in mmHg
3
Description
Total duration of surgery
Timepoint
end of surgery
Method of measurement
Digital timer
4
Description
Blood transfusion
Timepoint
end of surgery
Method of measurement
Number of packed cells transfused
Intervention groups
1
Description
continuous infusion of propofol (manufactured by Fresenius Kabi Austria GmbH) at dosage of 150 μ/kg/min is used for maintenance of anesthesia after induction. Infusion is performed for once during the whole operation time until the surgery is finished.
Category
Treatment - Drugs
2
Description
Inspiration of isoflurane (manufactured by Baxter corporation USA) at dosage of 1-1.5 % Maximum Alveolar Concentration for maintenance of anesthesia after induction. Inspiration of isoflurane is performed for once during the whole operation time until the end of surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Ebrahim Hazrati
Street address
Etemad Zadeh st, Fatemi st,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, AJA University of Medical Sciences
Full name of responsible person
Kamran Azma
Street address
Etemad zadeh st., Fatemi st.
City
Tehran
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, AJA 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Shaghaghi
Position
General practitioner
Other areas of specialty/work
Street address
Poursina st, Keshavarz Blvd,
City
Tehran
Postal code
Phone
+98 21 4401 1752
Fax
Email
mr-shaqaqi@student.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Mohammadreza Rafiei
Position
Anesthesiologist
Other areas of specialty/work
Street address
Etemad Zadeh st, Fatemi st,
City
Tehran
Postal code
Phone
+98 21 4382 3488
Fax
Email
m.rafiei@ajaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamadreza Shaghaghi
Position
General practitioner
Other areas of specialty/work
Street address
Poursina st, Keshavarz Blvd,
City
Tehran
Postal code
Phone
+98 21 4401 1752
Fax
Email
mr-shaqaqi@student.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)