Predictive effect of central venous pressure changes from passive leg elevation in homodynamic stability during anesthesia induction in adult cardiac surgery
Objective: Studying the predictive effect of central venous pressure changes from passive leg elevation in homodynamic stability during anesthesia induction in adult cardiac surgery
Design: Prospective randomized clinical trial
Setting and conduct: One hundred and twenty adult patients candidate for elective cardiac surgery, randomly will be allocated in two study and control groups (N=60). Using local anesthesia, arterial and central venous catheters placed and invasive arterial and central venous blood pressures will be monitored. Anesthesia will be induced using fentanyl, midazolam and cisatracurium. In study group patients, passive leg elevation (30-45 degrees) maneuver will performed one minute before anesthesia induction and got back to normal position, 12-15 minutes later. In control group anesthesia induction is performed in supine position. Invasive arterial and central venous pressures will be recorded one minute before and after induction, 5, 10 and 20 minutes after tracheal intubation. Hypotension below 100 mmHg will be treated using ephedrine 10 mg. At the end the arterial and central venous blood pressures changes within and between groups will be compared and predictive effect of central venous blood pressures changes after passive leg elevation maneuver on homodynamic stability will be calculated.
Inclusion criteria: Patients between 18-70 Years olds who are candidate for elective cardiac surgery
Exclusion criteria: Urgent surgery; redo surgery; non-cardiac disease (diabetes, hepatic and renal); Left Ventricular EF less than 40 percent; recent acute MI or unstable angina; systolic arterial blood pressures more than 160 mmHg
Intervention: Passive leg elevation maneuver before anesthesia induction
Outcome measures: Arterial and central venous blood pressures changes
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410111127N4
Registration date:2014-10-18, 1393/07/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-18, 1393/07/26
Registrant information
Name
Eissa Bilehjani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 6124
Email address
bilehjanii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Expected recruitment start date
2014-11-20, 1393/08/29
Expected recruitment end date
2015-08-20, 1394/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Predictive effect of central venous pressure changes from passive leg elevation in homodynamic stability during anesthesia induction in adult cardiac surgery
Public title
Predictive effect of central venous pressure changes from passive leg elevation in homodynamic stability during anesthesia induction in adult cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 18-70 Years olds who are candidate for elective cardiac surgery
Exclusion criteria: Urgent surgery; redo surgery; non-cardiac disease (diabetes, hepatic and renal); Left Ventricular EF less than 40 percent; recent acute MI or unstable angina; systolic arterial blood pressures more than 160 mmHg
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Tabriz University of Medical Sciences
Street address
Golgasht, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Approval date
2013-10-19, 1392/07/27
Ethics committee reference number
92215
Health conditions studied
1
Description of health condition studied
Drug induced hypotension in anesthesia induction
ICD-10 code
I95.2
ICD-10 code description
Hypotension due to drugs
Primary outcomes
1
Description
Central venous blood pressure changes after passive leg elevation maneuver
Timepoint
One, five, ten and twenty minutes after 5, 10 and 20 minutes after tracheal intubation
Method of measurement
Invasive central venous blood pressures measurement using electronic monitor
Secondary outcomes
1
Description
Arterial blood pressure changes after passive leg elevation maneuver
Timepoint
One, five, ten and twenty minutes after 5, 10 and 20 minutes after tracheal intubation
Method of measurement
Invasive arterial venous blood pressures measurement using electronic monitor
Intervention groups
1
Description
Intervention group: Passive leg elevation maneuver before anesthesia induction
Category
Treatment - Other
2
Description
Control group: Anesthesia induction in supine position
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Heart Hospital
Full name of responsible person
Eissa Bilehjani
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
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 Tabriz 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
Medicine faculty, Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleiman Pour
Position
Vice Chancellor for research of Tabriz University of Medical Sciences