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Comparison of fluid therapy based on plethysmographic Variability Index (PVI) and conventional method in spontaneous breathing patients on postoperative lactate levels in patients undergoing cesarian section surgery under spinal anesthesia

Protocol summary

Summary
Objectives: This study investigates the variability in the Pleth Variability Index on fluid management and correlation with lactate levels in patients candidate for cesarean section surgery. Design: This single centered randomized clinical trial is conducted on 70 patients who are candidate for cesarean section. Setting and Conduct: This study is taken place at Shariati hospital operating theater between April 2015 and April 2016. Participants: 70 pregnant women candidates for cesarean section delivery 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. 5 cc/kg crystalloid fluid is infused as the bolus, spinal anesthesia is induced and then in group A: 2cc/kg/hour of fluid is maintained, 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. In both groups, 10 mg ephedrine is given to keep mean arterial BP above 65 mmHg as needed. 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, and 5) the duration of surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016010525856N1
Registration date: 2017-01-14, 1395/10/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-14, 1395/10/25
Registrant information
Name
Siyamak Tavakoli
Name of organization / entity
Tehran Univercity
Country
Iran (Islamic Republic of)
Phone
+98 913 326 3724
Email address
s_tavakoli@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of fluid therapy based on plethysmographic Variability Index (PVI) and conventional method in spontaneous breathing patients on postoperative lactate levels in patients undergoing cesarian section surgery under spinal anesthesia
Public title
Fluid therapy in pregnancy in cesarian section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 18 to 50 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; Need to planned pharmacologic or mechanical cardiovascular manipulation; Needing repeated blood sampling; Failure of indirect arterial blood pressure measurement; Supplementary diagnostic information from the arterial waveform; Needing central venous pressure monitoring; Needing pulmonary artery catheterization and monitoring; Requiring transvenous cardiac pacing; Needing temporary hemodialysis; Need to aspirate air emboli; Inadequate peripheral intravenous access; Prolonged surgery (longer than 3 hours);
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
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
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
Postal code
Approval date
2015-06-08, 1394/03/18
Ethics committee reference number
IR.TUMS.REC.1394.1597

Health conditions studied

1

Description of health condition studied
Abnormal blood-pressure reading, without diagnosis
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis

Primary outcomes

1

Description
Total amount of intraoperative fluids infused after fluid therapy according to plethysmographic variability index (PVI)
Timepoint
End of surgery
Method of measurement
Milliliter

2

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

3

Description
Mean arterial pressure during fluid therapy according to PVI (plethysmographic variation index)
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 PVI (plethysmographic variation index)
Timepoint
End of surgery
Method of measurement
Milliliter

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
5 cc/kg crystalloid fluid is infused as the bolus, spinal anesthesia is induced and then 2cc/kg/hour of fluid is maintained, once PVI > 13 %, a 250 mL crystalloid is rapidly infused and repeated for every 5 minutes up to three times.
Category
Treatment - Other

2

Description
5 cc/kg crystalloid fluid is infused as the bolus, spinal anesthesia is induced and then 4-8 mL/kg/h crystalloid fluid infusion is maintained
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Dr. Siamak Tavakoli
Street address
Dr. Shariati Hospital, North Kargar Ave, Amirabad Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Vice Chancellor for research, Tehran University of Medical Sciences Tehran Tehran Iran, Islamic Republic Of Tehran
City
Tehran
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
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
Dr. Shariati Hospital
Full name of responsible person
Dr. Siamak Tavakoli
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Dr. Shariati Hospital, North Kargar Ave, Amirabad Tehran
City
Tehran
Postal code
Phone
+98 21 8822 0033
Fax
Email
S_tavakoli@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dr. Shariati Hospital
Full name of responsible person
Dr. Reza Atef Yekta
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Dr.Shariati Hospital, North Kargr ave, Amir Abad Tehran
City
Tehran
Postal code
Phone
+98 21 8822 0033
Fax
Email
rezaatefyekta@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Anesthesiology, Dr Shariati Hospital
Full name of responsible person
Dr. Siamak Tavakoli
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Dr. Shariati Hospital, North Kargar Ave, Amir Abad, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
S_tavakoli@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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