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

NCT02680678 | Completed

• 1 other identifier: BAU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications; Anesthesia, Spinal and Epidural, in Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Colloid preload

ACTIVE COMPARATOR

20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) 15 minutes before spinal anesthesia.

Other: Colloid Preload

Colloid Co-load

ACTIVE COMPARATOR

20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) beginning with spinal anesthesia.

Other: colloid co-load

Crystalloid Preload

ACTIVE COMPARATOR

20 patients each patient receives 20 ml/kg of Ringer's lactate solution 15 minutes before spinal anesthesia.

Other: Crystalloid preload

Crystalloid Co-load

ACTIVE COMPARATOR

20 patients each patient receives 20 ml/kg of Ringer's lactate solution beginning with spinal anesthesia.

Other: Crystalloid Co-load

Interventions

Colloid Preload OTHER

preload infusion

Also known as: Gelofusin

Colloid preload

colloid co-load OTHER

co-load infusion

Also known as: gelofusin

Colloid Co-load

Crystalloid preload OTHER

preload infusion

Also known as: Ringers lactate solution

Crystalloid Preload

Crystalloid Co-load OTHER

co-load infusion

Also known as: Ringers lactate solution

Crystalloid Co-load

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant 37-41 weeks
• one fetus
• scheduled for C/S under spinal anesthesia
• accepting to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Balikesir University: lead

Study Sites (1)

Balikesir University Faculty of Medicine

Balıkesir, 10145, Turkey (Türkiye)

Location

MeSH Terms

Interventions

succinylated gelatin; Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hafize Fisun Demir

  Balikesir University School of Medicine Department of Anesthesia and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the outcome accessor and care provider will be aware in which gropu the patient was
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 11, 2016
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)