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Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section

NCT04404946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-06-15

No results posted yet for this study

Summary

This will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section

Conditions

  • Hypotension Symptomatic
  • Vasoconstriction
  • Cesarean Section Complications
  • Obstetric Anesthesia Problems

Interventions

OTHER

phenylephrine infusion

in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated

OTHER

norepinephrine infusion

in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated

OTHER

placebo infusion

in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated

Sponsors & Collaborators

  • Aretaieion University Hospital

    lead OTHER

Principal Investigators

  • Kassiani Theodoraki, PhD, DESA · Aretaieion University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-23
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04404946 on ClinicalTrials.gov