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

NCT04026685 | Completed

• 1 other identifier: 2019-00866; qu18Buddeberg
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

caesarean delivery; phenylephrine; spinal anaesthesia; vasopressor administration; pregnancy; non invasive cardiac output (CO) monitoring (NICOM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping

• incidence of maternal nausea

  measured every minute after induction of spinal anaesthesia (=baseline) until 5 minutes after cord clamping

• Change in Apgar scores

  at 1 and 5 minutes after delivery

• Change in umbilical cord pH

  at 1 and 5 minutes after delivery

Study Arms (2)

Phenylephrine infusion only

ACTIVE COMPARATOR

Phenylephrine infusion only

Drug: Phenylephrine infusion

Phenylephrine infusion and Ringer-Acetate bolus

ACTIVE COMPARATOR

Phenylephrine infusion and Ringer-Acetate bolus

Drug: Phenylephrine infusion and Ringer-Acetate bolus

Interventions

Phenylephrine infusion DRUG

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

Phenylephrine infusion only

Phenylephrine infusion and Ringer-Acetate bolus DRUG

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

Phenylephrine infusion and Ringer-Acetate bolus

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Anaesthesiology, University Hospital of Basel (USB)

Basel, 4031, Switzerland

Location

Study Officials

• Bigna Buddeberg, Dr. med

  Department of Anaesthesiology, University Hospital of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Investigator and participant cannot see to which study group the participant belongs. The person performing randomisation and fluid application will not be involved in the data collection and Analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind, randomised controlled non-inferiority trial

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: January 9, 2020
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

CH (1)