Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Number of hypotension events with treatment related
Study Overview
Brief Summary
The purpose of this study is to compare the frequency of hypotension between hyperbaric anesthetics and isobaric anesthetics during cesarean section and determine whether continuous infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pregnant woman scheduled for elective cesarean delivery under spinal anesthesia
Exclusion Criteria
- •patients who refuse involved
- •patients who have pre-eclampsia
- •patients who have heart disease
- •patients who fetal distress is suspicious
Arms & Interventions
"BUPI","P"
patients who received hyperbaric bupivacaine and continous infusion of phenylephrine
Intervention: Bupivacaine (Drug)
"BUPI","P"
patients who received hyperbaric bupivacaine and continous infusion of phenylephrine
Intervention: Phenylephrine (Drug)
"BUPI","N"
patients who received hyperbaric bupivacaine and continous infusion of normal saline
Intervention: Bupivacaine (Drug)
"BUPI","N"
patients who received hyperbaric bupivacaine and continous infusion of normal saline
Intervention: normal saline (Drug)
"LEVO","P"
patients who received isobaric levobupivacaine and continous infusion of phenylephrine
Intervention: Levobupivacaine (Drug)
"LEVO","P"
patients who received isobaric levobupivacaine and continous infusion of phenylephrine
Intervention: Phenylephrine (Drug)
"LEVO","N"
patients who received isobaric levobupivacaine and continous infusion of normal saline
Intervention: Levobupivacaine (Drug)
"LEVO","N"
patients who received isobaric levobupivacaine and continous infusion of normal saline
Intervention: normal saline (Drug)
Outcomes
Primary Outcomes
Number of hypotension events with treatment related
Time Frame: during 30min after spinal anesthesia
blood pressure was obtained every 1min. A 20% decrease or more decrease in SAP compared to baseline was considered as hypotension. Hypotensive events during first 30 min was recorded as primary outcome.
Secondary Outcomes
- total dose of phenylephrine(during the surgery)
Investigators
Jae-Hyon Bahk, MD, PhD
Professor
Seoul National University Hospital