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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Hypotension

Treatments: Drug: normal saline; Drug: Bupivacaine; Drug: Levobupivacaine; Drug: Phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02802683

JHBahk_C/S

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

"BUPI","P"

Experimental group

Description:

patients who received hyperbaric bupivacaine and continous infusion of phenylephrine

Treatment:

Drug: Bupivacaine

Drug: Phenylephrine

"BUPI","N"

Placebo Comparator group

Description:

patients who received hyperbaric bupivacaine and continous infusion of normal saline

Treatment:

Drug: Bupivacaine

Drug: normal saline

"LEVO","P"

Experimental group

Description:

patients who received isobaric levobupivacaine and continous infusion of phenylephrine

Treatment:

Drug: Levobupivacaine

Drug: Phenylephrine

"LEVO","N"

Active Comparator group

Description:

patients who received isobaric levobupivacaine and continous infusion of normal saline

Treatment:

Drug: Levobupivacaine

Drug: normal saline