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

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

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.

Study Overview

• Status: Completed
• Conditions: Complications; Anesthesia, Spinal and Epidural, in Pregnancy
• Intervention / Treatment: Other: Colloid Preload; Other: colloid co-load; Other: Crystalloid preload; Other: Crystalloid Co-load

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Balikesir, Turkey, 10145
    • Balikesir University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Colloid preload; 20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) 15 minutes before spinal anesthesia.	Other: Colloid Preload; preload infusion; Other Names: Gelofusin
Active Comparator: Colloid Co-load; 20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) beginning with spinal anesthesia.	Other: colloid co-load; co-load infusion; Other Names: gelofusin
Active Comparator: Crystalloid Preload; 20 patients each patient receives 20 ml/kg of Ringer's lactate solution 15 minutes before spinal anesthesia.	Other: Crystalloid preload; preload infusion; Other Names: Ringers lactate solution
Active Comparator: Crystalloid Co-load; 20 patients each patient receives 20 ml/kg of Ringer's lactate solution beginning with spinal anesthesia.	Other: Crystalloid Co-load; co-load infusion; Other Names: Ringers lactate solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end.

Collaborators and Investigators

• Sponsor: Balikesir University
• Investigators: Principal Investigator: Hafize Fisun Demir, Balikesir University School of Medicine Department of Anesthesia and Reanimation

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (Estimate): February 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Pharmaceutical Solutions
• Other Study ID Numbers: BAU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO