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Hemodynamic Impact of Hyperbaric vs Isobaric Spinal Anesthesia for Cesarean Delivery
NCT02802683Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2015
- Primary completion
- May 2016
- Countries
- 1
- Sponsor
- Seoul National University Hospital
- Modality
- Small Molecules
- Drugs
- phenylephrine
- Conditions
- hypotension
01
Overview
Phase 4, randomised trial of phenylephrine in hypotension (4 arms), sponsored by Seoul National University Hospital. Primary endpoint: Number of hypotension events with treatment related. Started Sep 2015; status: completed.
02
Design
4 arms- Study design
- Randomized
Hyperbaric Bupivacaine + Phenylephrine
Spinal anesthesia with hyperbaric bupivacaine and continuous infusion of phenylephrine
Hyperbaric Bupivacaine + Saline
Spinal anesthesia with hyperbaric bupivacaine and continuous infusion of normal saline
Isobaric Levobupivacaine + Phenylephrine
Spinal anesthesia with isobaric levobupivacaine and continuous infusion of phenylephrine
Isobaric Levobupivacaine + Saline
Spinal anesthesia with isobaric levobupivacaine and continuous infusion of normal saline
03
Who it enrols
Pregnant women scheduled for elective cesarean delivery under spinal anesthesia. Excludes patients with pre-eclampsia, heart disease, or suspicious fetal distress.
04
Endpoints
Primary
Number of hypotension events with treatment related
Secondary
total dose of phenylephrine
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