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

Complications; Anesthesia, Spinal and Epidural, in Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680678
• Other study ID #: BAU
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2020
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Complications; Anesthesia, Spinal and Epidural, in Pregnancy
• Hypotension

Intervention

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

Locations

Country	Name	City	State
Turkey	Balikesir University Faculty of Medicine	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Balikesir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores	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.	Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end.