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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02680678
Enrollment
80
Registered
2016-02-11
Start date
2014-04-30
Completion date
2016-12-31
Last updated
2020-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications; Anesthesia, Spinal and Epidural, in Pregnancy

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.

Interventions

preload infusion

OTHERcolloid co-load

co-load infusion

OTHERCrystalloid preload

preload infusion

OTHERCrystalloid Co-load

co-load infusion

Sponsors

Balikesir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

the outcome accessor and care provider will be aware in which gropu the patient was

Intervention model description

4 group of patients were sheduled to receive either kristalloid or kolloid two gropus before and two groups during anesthesia induction

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026