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

Primary Purpose

Hypotension

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bupivacaine
Levobupivacaine
Phenylephrine
normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring Hypotension, cesarean section

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Active Comparator

Arm Label

"BUPI","P"

"BUPI","N"

"LEVO","P"

"LEVO","N"

Arm Description

patients who received hyperbaric bupivacaine and continous infusion of phenylephrine

patients who received hyperbaric bupivacaine and continous infusion of normal saline

patients who received isobaric levobupivacaine and continous infusion of phenylephrine

patients who received isobaric levobupivacaine and continous infusion of normal saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

total dose of phenylephrine

Full Information

First Posted
May 4, 2016
Last Updated
July 4, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02802683
Brief Title
Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Hypotension, cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"BUPI","P"
Arm Type
Experimental
Arm Description
patients who received hyperbaric bupivacaine and continous infusion of phenylephrine
Arm Title
"BUPI","N"
Arm Type
Placebo Comparator
Arm Description
patients who received hyperbaric bupivacaine and continous infusion of normal saline
Arm Title
"LEVO","P"
Arm Type
Experimental
Arm Description
patients who received isobaric levobupivacaine and continous infusion of phenylephrine
Arm Title
"LEVO","N"
Arm Type
Active Comparator
Arm Description
patients who received isobaric levobupivacaine and continous infusion of normal saline
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Heavy bupivacaine
Intervention Description
spinal anesthesia with hyperbaric bupivacaine
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Other Intervention Name(s)
chirocaine
Intervention Description
spinal anesthesia with isobaric levobupivacaine
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
continous infusion of phenylephrine
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
continous infusion of normal saline
Primary Outcome Measure Information:
Title
Number of hypotension events with treatment related
Description
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.
Time Frame
during 30min after spinal anesthesia
Secondary Outcome Measure Information:
Title
total dose of phenylephrine
Time Frame
during the surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahk
Organizational Affiliation
Seoul National University Hospital Seoul, Korea, Republic of
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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