Comparison of the effect of total intravenous anesthesia with Propofol and Midazolam on liver and renal function after tracheal resection & anastomosis surgery
Many factors contribute to postoperative hepatic and renal injury including anesthetic agents and type of surgery. This clinical study is planned to evaluate the effect of total intravenous anesthesia with Propofol and Midazolam on liver enzymes and renal function in the patients undergone tracheal resection and anastomosis surgery.70 American Society of Anesthesiologists physical status I and II patients scheduled for elective tracheal resection and anastomosis surgery, are randomly divided into 2 groups to receive either Propofol (n = 35) or Midazolaml (n = 35) for maintenance of anesthesia. Induction of anesthesia is similar in both groups. Preoperative serum levels of liver enzymes and renal tests including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), total bilirubin (TBil), and gamma-glutamyl transpeptidase (GTP), BUN and creatinin are compared with those on the first and third postoperative days in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110815322N1
Registration date:2014-01-17, 1392/10/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-17, 1392/10/27
Registrant information
Name
Shideh Dabir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2595
Email address
sdabir@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Tracheal Diseases Research Center, National Research Institute of Tuberculosis & Lung Diseasesl
Expected recruitment start date
2011-09-06, 1390/06/15
Expected recruitment end date
2013-12-15, 1392/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of total intravenous anesthesia with Propofol and Midazolam on liver and renal function after tracheal resection & anastomosis surgery
Public title
The effect of Propofol and Midazolam on liver and renal tests in patients undergoing tracheal resection surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Exclusion criteria: liver or renal disease; DM; preoperative baseline elevated level of liver enzymes and renal tests; alcohol or substance abuse; known allergy to study drugs;ASA class 3 or higher.
Inclusion criteria: normal preoperative baseline level of liver enzymes and renal tests; age ranging 16-60 years; ASA class 1 and 2.
Age
From 16 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
70
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
National Research Institute of Tuberculosis & Lung Diseases, Masih Daneshvari Hospital
Street address
Research office, Masih Daneshvari Hospital, Darabad, Nivaran
City
Tehran
Postal code
1955841452
Approval date
2009-04-09, 1388/01/20
Ethics committee reference number
640
Health conditions studied
1
Description of health condition studied
Intravenous anesthetic drug side effect
ICD-10 code
Y 48.1
ICD-10 code description
Parenteral anaesthetics
Primary outcomes
1
Description
Aspartate aminotransferase (AST)
Timepoint
before induction of anesthesia, on the first, and third postoperative days.
Method of measurement
Liasys AMS test
2
Description
Alanine aminotransferase (ALT)
Timepoint
Before induction of anesthesia, on the first, and third postoperative days.
Method of measurement
Liasys AMS test
3
Description
Total Bilirubin
Timepoint
Before induction of anesthesia, on the first, and third postoperative days.
Method of measurement
Liasys AMS test
4
Description
alkaline phosphatase
Timepoint
Before induction of anesthesia, on the first, and third postoperative days.
Method of measurement
Liasys AMS test
5
Description
G-glutamyltransferase
Timepoint
Before induction of anesthesia, on the first, and third postoperative days.
Method of measurement
Liasys AMS test
6
Description
Lactate dehydrogenase
Timepoint
Before induction of anesthesia, on the first, and third postoperative days.
Method of measurement
Liasys AMS test
7
Description
Blood Urea Nitrogen (BUN)
Timepoint
Before induction of anesthesia, on the first, and third postoperative days.
Method of measurement
Liasys AMS test
8
Description
Creatinine
Timepoint
Before induction of anesthesia, on the first, and third postoperative days.
Method of measurement
Liasys AMS test
Secondary outcomes
1
Description
Heart rate
Timepoint
Before induction of anesthesia (base line), 30 minutes after Induction of anesthesia, 1,2,3 and 4 hours after initiation of surgery, at the end of surgery
Method of measurement
Electrocardiogram
2
Description
Mean arterial blood pressure (MAP)
Timepoint
Before induction of anesthesia (base line),30 minutes after Induction of anesthesia, 1,2,3 and 4 hours after initiation of surgery, at the end of surgery
Method of measurement
sphygmomanometer
3
Description
Percent of arterial oxygen saturation (Spo2)
Timepoint
Before induction of anesthesia (base line),30 minutes after Induction of anesthesia, 1,2,3 and 4 hours after initiation of surgery, at the end of surgery
Method of measurement
pulse oximetry
Intervention groups
1
Description
Patients in the Midazolam group received continuous infusions of Midazolam 0.02- 0.04 mg/kg/hr for maintenance of anesthesia during surgery.
Category
Other
2
Description
Patients in the Propofol group received continuous infusions of propofol 100-200 µg/kg/min for maintenance of anesthesia during surgery.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Dr. Tahereh Parsa
Street address
Department of Anesthesiology, Masih Daneshvari Hospital،Darabad, Niavaran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Research Institute of Tuberculosis and Lung Diseases, Tracheal Diseases Research Center
Full name of responsible person
Iman Ghaydi
Street address
Department of Anesthesiology, Masih Daneshvari Hospital Darabad, Niavaran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Research Institute of Tuberculosis and Lung Diseases, Tracheal Diseases Research Center
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
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Dr. Tahereh Parsa
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Department of Anesthesiology, Masih Daneshvari Hospital, Darabad, Niavaran
City
Tehran
Postal code
1955841452
Phone
+98 21 2610 9644
Fax
+98 21 2610 9644
Email
tparsa849@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tracheal Diseases Research Center, NRITLD
Full name of responsible person
ِDr. Shideh Dabir
Position
M.D., Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Department of Anesthesiology, Masih Daneshvari Hospital, Darabad, Niavaran
City
Tehran
Postal code
1955841452
Phone
+98 21 2610 9644
Fax
+98 21 2610 9644
Email
shdabir@yahoo.com
sdabir@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
National Research Institute of Tuberculosis & Lung Diseases, Masih Daneshvari Hospital
Full name of responsible person
Dr. Shideh Dabir
Position
M.D.,Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Department of Anesthesiology, Masih Daneshvari Hospital, Darabad, Niavaran
City
Tehran
Postal code
1955841452
Phone
+98 21 2610 9644
Fax
+98 21 2610 9644
Email
sdabir@sbmu.ac.irshdabir@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)