Comparison of the effect of fluid therapy based on plethysmographic Variability Index (PVI) and conventional method on postoperative lactate levels in patients undergoing thyroidectomy surgery
Objectives: This study investigates the variability in the Pleth Variability Index on fluid management and correlation with lactate levels. Design: Single centered randomized clinical trial. Setting and Conduct: This study is taken place at Shariati hospital operating theater between April 2017 and September 2017. Participants: 50 patients candidate for elective thyroidectomy Intervention: The patients are randomly assigned to one of the Pleths variability index or conventional groups. Arterial blood sample is extracted and sent to laboratory to measure serum lactate level. General anesthesia is induced and then in group A: once PVI > 13 %, a 250 mL crystalloid is rapidly infused and repeated for every 5 minutes up to three times. In group B: 4-8 mL/kg/h crystalloid fluid infusion is maintained, and quick fluid infusion is initiated if mean arterial blood pressure (MAP) < 65 mmHg . Outcome measures: 1) the serum level of lactate on admission as well as at the end of surgery, 2) mean arterial pressure before anesthesia as well as 1, 2, 3, and 5 minutes after that, 3) the total amount of intraoperative fluids infused, 4) the amount of urine output within surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410285140N14
Registration date:2017-04-19, 1396/01/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-19, 1396/01/30
Registrant information
Name
Omid Azimaraghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 6194
Email address
cazimaraghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of fluid therapy based on plethysmographic Variability Index (PVI) and conventional method on postoperative lactate levels in patients undergoing thyroidectomy surgery
Public title
Fluid therapy in Thyroidectomy Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 18 to 60 years; American Society of anesthesiologists physical status class I and II; A body mass index (BMI) less than 30 kilograms per cubic meter.
Exclusion criteria: History of systemic (cardiovascular, renal, hepatic, or vascular) disorders; Inadequate peripheral intravenous access; Prolonged surgery (longer than 3 hours);intraoperative dysrhythmias;
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
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 Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
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
R83-R89
ICD-10 code description
Abnormal findings on examination of other body fluids, substances and tissues, without diagnosis
Primary outcomes
1
Description
Amounts of lactate in fluid therapy according to PVI (plethysmographic variation Index)
Timepoint
On admission as well as at the end of surgery
Method of measurement
Millimole/liter , Enzymatic
Secondary outcomes
1
Description
Total amount of intraoperative fluids infused after fluid therapy according to conventional method
Timepoint
End of surgery
Method of measurement
Milliliter
2
Description
Amounts of lactate in fluid therapy according to conventional method
Timepoint
on admission as well as at the end of surgery
Method of measurement
Millimole/liter, Enzymatic
3
Description
Mean arterial pressure during fluid therapy according to conventional method
Timepoint
Before anesthesia as well as 1, 2, 3, and 5 minutes after that
Method of measurement
Using patients monitoring - millimeter of mercury
4
Description
Total amounts of Urine output after fluid therapy according to conventional method
Timepoint
End of surgery
Method of measurement
Milliliter
Intervention groups
1
Description
In group A: During surgery once PVI > 13 %, a 250 mL crystalloid is infused and repeated for every 5 minutes up to three times.
Category
Treatment - Drugs
2
Description
In group B: 4-8 mL/kg/h crystalloid fluid infusion is maintained, and quick fluid infusion is initiated if mean arterial blood pressure (MAP) < 65 mmHg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr. Ali Movafegh
Street address
Dr. Shariati Hospital, North Kargar Ave, Amir Abad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research-Faculty of Medicine-Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Tehran University of Medical Sciences, Poorsina street ,Keshavarz avenue,
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 of research-Faculty of Medicine-Tehran 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
Professor of Anesthesiology, Dr shariati Hospital
Full name of responsible person
Dr Ali Movafegh
Position
Full Professor
Other areas of specialty/work
Street address
Dr. Shariati Hospital, North Kargar Ave, Amir Abad, Tehran
City
Tehran
Postal code
Phone
+98 21 8490 2282
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology, Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Movafegh
Position
Full Professor
Other areas of specialty/work
Street address
Dr. Shariati Hospital, North Kargar Ave, Amir Abad, Tehran
City
Tehran
Postal code
Phone
+98 21 8490 2282
Fax
Email
movafegh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dr Shariati Hospital
Full name of responsible person
Omid Azimaraghi
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Dr. Shariati Hospital, North Kargar Ave, Amir Abad, Tehran
City
Tehran
Postal code
Phone
+98 21 2206 6194
Fax
+98 21 2206 6194
Email
o-azimaraghi@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)