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

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.

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.

Study Overview

• Status: Completed
• Conditions: Maternal Haemodynamic Stability
• Intervention / Treatment: Drug: Phenylephrine infusion; Drug: Phenylephrine infusion and Ringer-Acetate bolus

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Anaesthesiology, University Hospital of Basel (USB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phenylephrine infusion only	Drug: Phenylephrine infusion; continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure
Active Comparator: Phenylephrine infusion and Ringer-Acetate bolus	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maternal heart rate	Change in maternal heart rate	measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
Change in maternal diastolic and systolic blood pressure	Change in maternal diastolic and systolic blood pressure (mmHg)	measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
incidence of maternal nausea	incidence of maternal Nausea (number)	measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping
Change in Apgar scores	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).	at 1 and 5 minutes after delivery
Change in umbilical cord pH	Change in umbilical cord pH	at 1 and 5 minutes after delivery

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Bigna Buddeberg, Dr. med, Department of Anaesthesiology, University Hospital of Basel

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Actual): February 5, 2021
• Study Completion (Actual): February 5, 2021

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: pregnancy; spinal anaesthesia; phenylephrine; caesarean delivery; vasopressor administration; non invasive cardiac output (CO) monitoring (NICOM)
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine; Oxymetazoline
• Other Study ID Numbers: 2019-00866; qu18Buddeberg

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No