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

Not Applicable

Completed

• Conditions: Complications; Anesthesia, Spinal and Epidural, in Pregnancy
• Interventions: Other: Crystalloid Co-load; Other: Colloid Preload; Other: Crystalloid preload; Other: colloid co-load

• Registration Number: NCT02680678
• Lead Sponsor: Balikesir University

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-11
• Primary Completion: 2016-08
• Study Completion: 2016-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crystalloid Co-load	Crystalloid Co-load	20 patients each patient receives 20 ml/kg of Ringer's lactate solution beginning with spinal anesthesia.
Colloid preload	Colloid Preload	20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) 15 minutes before spinal anesthesia.
Crystalloid Preload	Crystalloid preload	20 patients each patient receives 20 ml/kg of Ringer's lactate solution 15 minutes before spinal anesthesia.
Colloid Co-load	colloid co-load	20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) beginning with spinal anesthesia.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Balikesir University Faculty of Medicine; 🇹🇷 Balikesir, Turkey