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Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02802683
Enrollment
72
Registered
2016-06-16
Start date
2015-09-30
Completion date
2016-06-30
Last updated
2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

Hypotension, cesarean section

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.

Interventions

DRUGBupivacaine

spinal anesthesia with hyperbaric bupivacaine

DRUGLevobupivacaine

spinal anesthesia with isobaric levobupivacaine

DRUGPhenylephrine

continous infusion of phenylephrine

DRUGnormal saline

continous infusion of normal saline

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Number of hypotension events with treatment relatedduring 30min after spinal anesthesiablood 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

MeasureTime frame
total dose of phenylephrineduring the surgery

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026