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Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery

NCT04026685 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-02-17

No results posted yet for this study

Summary

Spinal anaesthesia is the anaesthetic technique of choice for elective caesarean delivery. Hypotension, a result of the decrease in systemic vascular resistance caused by spinal anaesthesia, is a frequent complication occurring in up to 80%. This study is to investigate fluid loading plus vasopressors to vasopressors alone to maintain stable maternal haemodynamics in elective caesarean delivery. The effect of the two methods (continuous prophylactic phenylephrine infusion with and without crystalloid co-loading) on maternal haemodynamics will be compared using the Starling SV Monitor. The Starling SV device is a non invasive cardiac output monitor (NICOM) which is certified and validated for the use in pregnancy.

Conditions

  • Maternal Haemodynamic Stability

Interventions

DRUG

Phenylephrine infusion

continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure

DRUG

Phenylephrine infusion and Ringer-Acetate bolus

continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure plus crystalloid Ringer-Acetate co-loading bolus of 1000 mL

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Bigna Buddeberg, Dr. med · Department of Anaesthesiology, University Hospital of Basel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2021-02-05
Completion
2021-02-05

Countries

  • Switzerland

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 NCT04026685 on ClinicalTrials.gov