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Completed

NCT Number: NCT02680678

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 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.

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Key information

Conditions

Complications; Anesthesia, Spinal and Epidural, in Pregnancy

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Balikesir University Faculty of Medicine

Balıkesir, 10145, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colloid Preload

Other

preload infusion

Other names: Gelofusin

colloid co-load

Other

co-load infusion

Other names: gelofusin

Crystalloid preload

Other

preload infusion

Other names: Ringers lactate solution

Crystalloid Co-load

Other

co-load infusion

Other names: Ringers lactate solution

Primary outcomes

  1. Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores

    Time frame: Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end.

    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.

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 11, 2016
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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