Skip to main content
Clinical Trials/NCT02680678
NCT02680678
Completed
Not Applicable

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

Balikesir University1 site in 1 country80 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complications; Anesthesia, Spinal and Epidural, in Pregnancy
Sponsor
Balikesir University
Enrollment
80
Locations
1
Primary Endpoint
Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
December 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Balikesir University
Responsible Party
Principal Investigator
Principal Investigator

hafize fisun demir

Assistant Professor

Balikesir University

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials