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

University Hospital Basel

Status

Completed

Conditions

Maternal Haemodynamic Stability

Treatments

Drug: Phenylephrine infusion and Ringer-Acetate bolus

Drug: Phenylephrine infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT04026685

2019-00866 qu18Buddeberg;

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)