Comparative evaluation of effects of different tidal volumes of mechanical ventilation on hemodynamic indices during deliberate hypotension by using nitroprosside & nitroglycerine in ear microsurgery patients
This study was designed to compare effects of different tidal volumes (5, 10 and 15 cc/kg) on hemodynamic indices (HR, BP, SV, CO, …) during controlled hypotension which induced by continuous infusion of Nitroglycerin (0.5 to 30 µg/kg/min) or Na Nitroprusside (1 to 8 µg/kg/min) in middle ear microsurgery operations. In a double blind clinical trial, sixty anesthetized patients allocate randomly in two groups and randomly take 10 minutes trials of different tidal volumes in normotension and hypotension states. Hemodynamic indices measure at the end of each trial of tidal volume and compare between two groups. A coworker prescribes hypotensive drugs and drugs remain blind to main researcher till end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014020516415N2
Registration date:2014-07-14, 1393/04/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-14, 1393/04/23
Registrant information
Name
Mohammad Golparvar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3220 1750
Email address
golparvar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of effects of different tidal volumes of mechanical ventilation on hemodynamic indices during deliberate hypotension by using nitroprosside & nitroglycerine in ear microsurgery patients
Public title
Effects of different tidal volumes on hemodynamic indices during deliberate hypotension by using nitroprosside & nitroglycerin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA 1 and 2; non smokers; no cardiopulmonary and renal disease; candidates for elective middle ear microsurgery.
Exclusion criteria: Bleeding more than 2cc/kg; bronchospasm during surgery; need to other hypotensive drugs other than drugs of study.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjarib Boulevard, Isfahan, Iran
Measurement by anesthesia monitoring system and TECO (Trans Esophageal Cardiac Output measurement)
Secondary outcomes
1
Description
Peak airway pressure, Plateu airway pressure
Timepoint
At the end of each trial different tidal volumes
Method of measurement
By ventilator of anesthesia mashine
Intervention groups
1
Description
First group: changing tidal volume between 5, 10 and 15 ml/kg during infusion of nitroglycerin.
Nitroglycerin infusees in 0.5 mic/kg after induction of anesthesia and increase till 30% decrease in mean blood pressure (target blood pressure) and then infusion speed changes to serve mean blood pressure within 20% of target blood pressure)
Category
Treatment - Drugs
2
Description
Second group: changing tidal volume between 5, 10 and 15 ml/kg during infusion of Na nitroprusside.
Na Nitroprusside infusees in 1 mic/kg after induction of anesthesia and increase till 30% decrease in mean blood pressure (target blood pressure) and then infusion speed changes to serve mean blood pressure within 20% of target blood pressure).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical Center
Full name of responsible person
Golparvar M. MD
Street address
Department of Anesthesia, Alzahra Medical center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ali M Sabzghabaee
Street address
Research manager office, Deputy of research and technology, Isfahan University of Medical Sciences; Hezarjarib Boulevard, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar M MD
Position
Associate professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of Anesthesia, Alzahra Medical center, Sofeh boulvard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar Mohammad MD
Position
Associate Professor of Anesthesia and Critical Care Group
Other areas of specialty/work
Street address
Department of anesthesia, Alzahra Medical Center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar Mohammad MD
Position
Associate professor of Anesthesia and critical Care Group
Other areas of specialty/work
Street address
Department of anesthesia, Alzahra Medical Center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)