Comparison of fluid therapy based on plethysmographic Variability Index (PVI) and the conventional method on intraoperative lactate levels in patients undergoing Thyroidectomy surgery
Compare the changes in intraoperative serum lactate levels with plethsvariability index guided intraoperative fluid therapy in comparison to the conventional approach
Design
Pleths and conventional group,parallel group, single blind
Settings and conduct
Operating room
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients aged 18−65 years
American Society Anesthesiology class I,II
Elective Thyroidectomy Surgery
Exclusion Criteria:
Cardiac arrhythmia
Lung diseases
Intraoperative bleeding was >300 mL
Duration of surgery was >3 hours
Intervention groups
In the Pleths group, 5 cc/kg bolus of normal saline was administered prior to anesthesia and continuous crystalloid infusion using 2 mL/kg/h of normal saline was administered throughout the surgery. If the PVI was >13% for 5 min, a 100 mL bolus of normal saline was administered and repeated until the PVI reached 13%.
In the conventional group, 5 cc/kg bolus of normal saline was administered prior to anesthesia induction and continuous crystalloid infusion (5 mL/kg/h) was administered throughout the surgery.
Main outcome variables
Serum Lactate Levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150929024268N3
Registration date:2018-10-03, 1397/07/11
Registration timing:retrospective
Last update:2018-10-03, 1397/07/11
Update count:0
Registration date
2018-10-03, 1397/07/11
Registrant information
Name
omid azimaraghi
Name of organization / entity
Department of Anesthesia
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2436
Email address
o-azimaraghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-23, 1396/10/02
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
2017-05-23, 1396/03/02
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
2018-05-22, 1397/03/01
Scientific title
Comparison of fluid therapy based on plethysmographic Variability Index (PVI) and the conventional method on intraoperative lactate levels in patients undergoing Thyroidectomy surgery
Public title
Intraoperative Fluid therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18−65 years
American Society Anesthesiology class I,II
Elective Thyroidectomy Surgery
Exclusion criteria:
Cardiac arrhythmia
Lung diseases
Intraoperative bleeding was >300 mL
Duration of surgery was >3 hours
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Prepared computer-based randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee, Faculty of Medicine of Tehran University of Medical Sciences
Street address
Research Deputy, Ethics Committee of Tehran University of Medical Sciences, 6th floor, Tehran University of Medical Sciences building, Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
14155-6559
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.TUMS.VCR.REC.1395.879
Health conditions studied
1
Description of health condition studied
Fluid Therapy
ICD-10 code
E87.8
ICD-10 code description
Other disorders of electrolyte and fluid balance, not elsewhere classified
Primary outcomes
1
Description
Serum Lactate
Timepoint
Before Anesthesia and at the end of surgery
Method of measurement
blood sample
Secondary outcomes
1
Description
Amount of fluid
Timepoint
From before anesthesia and till the end of anesthesia
Method of measurement
millimeters
Intervention groups
1
Description
Intervention group: In the Pleths group, 5 cc/kg bolus of normal saline was administered prior to anesthesia and continuous crystalloid infusion using 2 mL/kg/h of normal saline was administered throughout the surgery. If the PVI was >13% for 5 min, a 100 mL bolus of normal saline was administered and repeated until the PVI reached 13%.
Category
Other
2
Description
Control group: In the conventional group, 5 cc/kg bolus of normal saline was administered prior to anesthesia induction and continuous crystalloid infusion (5 mL/kg/h) was administered throughout the surgery.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital,Tehran University of Medical Sciences
Full name of responsible person
Omid Azimaraghi
Street address
Dr. Shariati Hospital, North Kargar Ave, Amirabad Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2282
Email
o.azimaraghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Dr. Shariati Hospital, Jalal-Al-Ahmad, Kargar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
dralimovafegh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Movafegh
Position
Full Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Dr. Shariati Hospital, Jalal-Al-Ahmad, Kargar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 2282
Email
movafegh@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid Azimaraghi
Position
Assistant Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Dr. Shariati Hospital, Jalal-Al-Ahmad, Kargar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 84902282
Email
o.azimaraghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Omid Azimaraghi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Dr. Shariati Hospital, Jalal-Al-Ahmad, Kargar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 84902282
Email
o.azimaraghi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified data sets are to be shared
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
If the source is mentioned its allowed to use data.
From where data/document is obtainable
Email to corresponding author: dralimovafegh@gmail.com
What processes are involved for a request to access data/document
Email to corresponding author and the access will be granted in less than a month