Status:
COMPLETED
Maternal Haemodynamic Changes After Crystalloid Co-loading and Phenylephrine Versus Phenylephrine Alone During Spinal Anaesthesia for Elective Caesarean Delivery
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Maternal Haemodynamic Stability
Eligibility:
FEMALE
18+ years
Phase:
NA
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 freq...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04026685
Start Date
January 9 2020
End Date
February 5 2021
Last Update
February 17 2021
Active Locations (1)
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1
Department of Anaesthesiology, University Hospital of Basel (USB)
Basel, Switzerland, 4031