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

Phase 4

Completed

• Conditions: Hypotension
• Interventions: Drug: Bupivacaine; Drug: Levobupivacaine; Drug: normal saline; Drug: Phenylephrine

• Registration Number: NCT02802683
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-05
• Study First Submitted: 2016-05-04
• Study Completion: 2016-06
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-04
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"LEVO","N"	normal saline	patients who received isobaric levobupivacaine and continous infusion of normal saline
"BUPI","P"	Bupivacaine	patients who received hyperbaric bupivacaine and continous infusion of phenylephrine
"BUPI","N"	normal saline	patients who received hyperbaric bupivacaine and continous infusion of normal saline
"BUPI","P"	Phenylephrine	patients who received hyperbaric bupivacaine and continous infusion of phenylephrine
"BUPI","N"	Bupivacaine	patients who received hyperbaric bupivacaine and continous infusion of normal saline
"LEVO","P"	Levobupivacaine	patients who received isobaric levobupivacaine and continous infusion of phenylephrine
"LEVO","P"	Phenylephrine	patients who received isobaric levobupivacaine and continous infusion of phenylephrine
"LEVO","N"	Levobupivacaine	patients who received isobaric levobupivacaine and continous infusion of normal saline

Primary Outcome Measures

Name	Time	Method
Number of hypotension events with treatment related	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 Outcome Measures

Name	Time	Method
total dose of phenylephrine	during the surgery

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of