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

NCT ID: NCT02802683

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Hypotension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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"BUPI","P"

patients who received hyperbaric bupivacaine and continous infusion of phenylephrine

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

spinal anesthesia with hyperbaric bupivacaine

Phenylephrine

Intervention Type DRUG

continous infusion of phenylephrine

"BUPI","N"

patients who received hyperbaric bupivacaine and continous infusion of normal saline

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

spinal anesthesia with hyperbaric bupivacaine

normal saline

Intervention Type DRUG

continous infusion of normal saline

"LEVO","P"

patients who received isobaric levobupivacaine and continous infusion of phenylephrine

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type DRUG

spinal anesthesia with isobaric levobupivacaine

Phenylephrine

Intervention Type DRUG

continous infusion of phenylephrine

"LEVO","N"

patients who received isobaric levobupivacaine and continous infusion of normal saline

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

spinal anesthesia with isobaric levobupivacaine

normal saline

Intervention Type DRUG

continous infusion of normal saline

Interventions

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Bupivacaine

spinal anesthesia with hyperbaric bupivacaine

Intervention Type DRUG

Levobupivacaine

spinal anesthesia with isobaric levobupivacaine

Intervention Type DRUG

Phenylephrine

continous infusion of phenylephrine

Intervention Type DRUG

normal saline

continous infusion of normal saline

Intervention Type DRUG

Other Intervention Names

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Heavy bupivacaine chirocaine

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Hyon Bahk, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bahk

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital Seoul, Korea, Republic of

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JHBahk_C/S

Identifier Type: -

Identifier Source: org_study_id

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