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

Overview

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.

Full Title of Study: “Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery: a Double-blind, Randomised Controlled Trial Using the Non Invasive Cardiac Output Monitor StarlingTM SV.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 5, 2021

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

Arms, Groups and Cohorts

  • Active Comparator: Phenylephrine infusion only
    • Phenylephrine infusion only
  • Active Comparator: Phenylephrine infusion and Ringer-Acetate bolus
    • Phenylephrine infusion and Ringer-Acetate bolus

Clinical Trial Outcome Measures

Primary Measures

  • Change in maternal cardiac output (CO)
    • Time Frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
    • CO measured by area under the curve (AUC) (L/min.)

Secondary Measures

  • Change in maternal heart rate
    • Time Frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
    • Change in maternal heart rate
  • Change in maternal diastolic and systolic blood pressure
    • Time Frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
    • Change in maternal diastolic and systolic blood pressure (mmHg)
  • incidence of maternal nausea
    • Time Frame: measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
    • incidence of maternal Nausea (number)
  • Change in Apgar scores
    • Time Frame: at 1 and 5 minutes after delivery
    • The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration).
  • Change in umbilical cord pH
    • Time Frame: at 1 and 5 minutes after delivery
    • Change in umbilical cord pH

Participating in This Clinical Trial

Inclusion Criteria

  • Ability to give informed consent – Term uncomplicated singleton pregnancy – Undergoing elective caesarean section under spinal anaesthesia – Weight: 50-100kg – Height: 150-180cm – Healthy term fetus Exclusion Criteria:

  • Inability to give informed consent – Multiple pregnancy – Clinically significant concomitant disease states (e.g. hypertension, cardiac disease, severe asthma requiring regular medication, comorbidities affecting the autonomous nervous system, renal disease) – On any cardiovascular medication – Complications of pregnancy (e.g. preeclampsia, intrauterine growth restriction, fetal malformations) – Known or suspected non-compliance, drug or alcohol abuse – Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the participant, – Participation in another study with investigational drug within the 30 days preceding and during the present study, – Previous enrolment into the current study, – Enrolment of the investigator, his/her family members, employees and other dependent persons – Any fetal pathology (e.g. fetal malformations, rupture of membranes before caesarean section, oligohydramnios, polyhydramnios, suspected chorioamnionitis)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bigna Buddeberg, Dr. med, Principal Investigator, Department of Anaesthesiology, University Hospital of Basel

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