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The Effect of the Timing of Colloid and Crystalloid Infusions on Postspinal Hypotension After Spinal Anesthesia for Caesarian Section

Primary Purpose

Complications; Anesthesia, Spinal and Epidural, in Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Colloid Preload
colloid co-load
Crystalloid preload
Crystalloid Co-load
Sponsored by
Balikesir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complications; Anesthesia, Spinal and Epidural, in Pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • pregnant 37-41 weeks
  • one fetus
  • scheduled for C/S under spinal anesthesia
  • accepting to participate

Exclusion Criteria:

  • Emergency surgery
  • placenta previa
  • preeclampsia
  • cardiovascular and cerebrovascular comorbidities
  • morbid obesity (BMI>40)
  • pregnancy weeks <36 and > 41
  • The use of vasoconstrictors
  • Severe Anemia ( Hb <9 g/dl)
  • Refusal or known contraindication for spinal anesthesia

Sites / Locations

  • Balikesir University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Colloid preload

Colloid Co-load

Crystalloid Preload

Crystalloid Co-load

Arm Description

20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) 15 minutes before spinal anesthesia.

20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) beginning with spinal anesthesia.

20 patients each patient receives 20 ml/kg of Ringer's lactate solution 15 minutes before spinal anesthesia.

20 patients each patient receives 20 ml/kg of Ringer's lactate solution beginning with spinal anesthesia.

Outcomes

Primary Outcome Measures

Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores
Hypotension is going tobe measured in mmHG in 5 minute intervals and PI and PVI measurements are also recorded at the same time intervals. A decrease in blood presssure exceeding % 20 of the preoperative basal blood pressure measurement will be recorded as hypotension. The number of patients who develop hypotension will be recorded. Statistic difference will be avaluated between groups. Hypotensive episodes are going to be comparised with the PI and PVI measurements at the same time period and evaluation for correlation will be performed.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2016
Last Updated
January 17, 2020
Sponsor
Balikesir University
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1. Study Identification

Unique Protocol Identification Number
NCT02680678
Brief Title
The Effect of the Timing of Colloid and Crystalloid Infusions on Postspinal Hypotension After Spinal Anesthesia for Caesarian Section
Official Title
Prevention of Postspinal Hypotension After Spinal Anesthesia for Caesarian Section, the Comparison of Crystalloid and Colloid Infusions and Their Timing Via Perfusion Index and Plethysmographic Variability Index
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balikesir University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid infusions and their timing via perfusion index and plethysmographic variability index.
Detailed Description
To Prevent hypotension fluid replacement is usually used in pregnant patients scheduled for C/S. Different types of fluids can be used in order to achieve this. Also the timing of fluid replacement is important. In the present study patients were separated into 4 groups. Each receiving a one of two fluids in different times. ( Colloid pre-load, colloid co-load, crystalloid co-load and crystalloid pre-load.) The effect of overall hemodynamics and the incidence of hypotension are evaluated. Also peripheric monitors like perfusion index and plethysmographic variability index are evaluated for correlation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Anesthesia, Spinal and Epidural, in Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 group of patients were sheduled to receive either kristalloid or kolloid two gropus before and two groups during anesthesia induction
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
the outcome accessor and care provider will be aware in which gropu the patient was
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colloid preload
Arm Type
Active Comparator
Arm Description
20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) 15 minutes before spinal anesthesia.
Arm Title
Colloid Co-load
Arm Type
Active Comparator
Arm Description
20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) beginning with spinal anesthesia.
Arm Title
Crystalloid Preload
Arm Type
Active Comparator
Arm Description
20 patients each patient receives 20 ml/kg of Ringer's lactate solution 15 minutes before spinal anesthesia.
Arm Title
Crystalloid Co-load
Arm Type
Active Comparator
Arm Description
20 patients each patient receives 20 ml/kg of Ringer's lactate solution beginning with spinal anesthesia.
Intervention Type
Other
Intervention Name(s)
Colloid Preload
Other Intervention Name(s)
Gelofusin
Intervention Description
preload infusion
Intervention Type
Other
Intervention Name(s)
colloid co-load
Other Intervention Name(s)
gelofusin
Intervention Description
co-load infusion
Intervention Type
Other
Intervention Name(s)
Crystalloid preload
Other Intervention Name(s)
Ringers lactate solution
Intervention Description
preload infusion
Intervention Type
Other
Intervention Name(s)
Crystalloid Co-load
Other Intervention Name(s)
Ringers lactate solution
Intervention Description
co-load infusion
Primary Outcome Measure Information:
Title
Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores
Description
Hypotension is going tobe measured in mmHG in 5 minute intervals and PI and PVI measurements are also recorded at the same time intervals. A decrease in blood presssure exceeding % 20 of the preoperative basal blood pressure measurement will be recorded as hypotension. The number of patients who develop hypotension will be recorded. Statistic difference will be avaluated between groups. Hypotensive episodes are going to be comparised with the PI and PVI measurements at the same time period and evaluation for correlation will be performed.
Time Frame
Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pregnant 37-41 weeks one fetus scheduled for C/S under spinal anesthesia accepting to participate Exclusion Criteria: Emergency surgery placenta previa preeclampsia cardiovascular and cerebrovascular comorbidities morbid obesity (BMI>40) pregnancy weeks <36 and > 41 The use of vasoconstrictors Severe Anemia ( Hb <9 g/dl) Refusal or known contraindication for spinal anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafize Fisun Demir
Organizational Affiliation
Balikesir University School of Medicine Department of Anesthesia and Reanimation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balikesir University Faculty of Medicine
City
Balikesir
ZIP/Postal Code
10145
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of the Timing of Colloid and Crystalloid Infusions on Postspinal Hypotension After Spinal Anesthesia for Caesarian Section

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