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NCT02802683 Clinical Trial

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

Hypotension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02802683
Other study ID # JHBahk_C/S
Secondary ID
Status Completed
Phase Phase 4
First received May 4, 2016
Last updated July 4, 2016
Start date September 2015
Est. completion date June 2016

Study information
Verified date July 2016
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date June 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Bupivacaine
spinal anesthesia with hyperbaric bupivacaine
• Levobupivacaine
spinal anesthesia with isobaric levobupivacaine
• Phenylephrine
continous infusion of phenylephrine
• normal saline
continous infusion of normal saline

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of hypotension events with treatment related 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. during 30min after spinal anesthesia Yes
Secondary total dose of phenylephrine during the surgery Yes
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Active, not recruiting NCT05250960 - Pre-epidural SCDs to Prevent Hypotension During Labor N/A