Overview

This trial is active, not recruiting.

Condition complications; anesthesia, spinal and epidural, in pregnancy
Treatments colloid preload, colloid co-load, crystalloid preload, crystalloid co-load
Phase phase 4
Sponsor Balikesir University
Start date April 2014
End date August 2016
Trial size 80 participants
Trial identifier NCT02680678, BAU

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Active Comparator)
20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) 15 minutes before spinal anesthesia.
colloid preload Gelofusin
preload infusion
(Active Comparator)
20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) beginning with spinal anesthesia.
colloid co-load gelofusin
co-load infusion
(Active Comparator)
20 patients each patient receives 20 ml/kg of Ringer's lactate solution 15 minutes before spinal anesthesia.
crystalloid preload Ringers lactate solution
preload infusion
(Active Comparator)
20 patients each patient receives 20 ml/kg of Ringer's lactate solution beginning with spinal anesthesia.
crystalloid co-load Ringers lactate solution
co-load infusion

Primary Outcomes

Measure
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.

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

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
Principal investigator Hafize Fisun Demir
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Balikesir University.