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

B

Balikesir University

Status

Completed

Conditions

Complications; Anesthesia, Spinal and Epidural, in Pregnancy

Treatments

Other: Crystalloid Co-load
Other: colloid co-load
Other: Colloid Preload
Other: Crystalloid preload

Study type

Interventional

Funder types

Other

Identifiers

NCT02680678
BAU

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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