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

NCT02802683 | Completed Phase 4

• 1 other identifier: JHBahk_C/S
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Keywords

Hypotension; cesarean section

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• total dose of phenylephrine

  during the surgery

Study Arms (4)

"BUPI","P"

EXPERIMENTAL

patients who received hyperbaric bupivacaine and continous infusion of phenylephrine

Drug: Bupivacaine; Drug: Phenylephrine

"BUPI","N"

PLACEBO COMPARATOR

patients who received hyperbaric bupivacaine and continous infusion of normal saline

Drug: Bupivacaine; Drug: normal saline

"LEVO","P"

EXPERIMENTAL

patients who received isobaric levobupivacaine and continous infusion of phenylephrine

Drug: Levobupivacaine; Drug: Phenylephrine

"LEVO","N"

ACTIVE COMPARATOR

patients who received isobaric levobupivacaine and continous infusion of normal saline

Drug: Levobupivacaine; Drug: normal saline

Interventions

Bupivacaine DRUG

spinal anesthesia with hyperbaric bupivacaine

Also known as: Heavy bupivacaine

"BUPI","N"; "BUPI","P"

Levobupivacaine DRUG

spinal anesthesia with isobaric levobupivacaine

Also known as: chirocaine

"LEVO","N"; "LEVO","P"

Phenylephrine DRUG

continous infusion of phenylephrine

"BUPI","P"; "LEVO","P"

normal saline DRUG

continous infusion of normal saline

"BUPI","N"; "LEVO","N"

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant woman scheduled for elective cesarean delivery under spinal anesthesia

You may not qualify if:

• patients who refuse involved
• patients who have pre-eclampsia
• patients who have heart disease
• patients who fetal distress is suspicious

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Hypotension

Interventions

Bupivacaine; Levobupivacaine; Phenylephrine; Saline Solution

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bahk

  Seoul National University Hospital Seoul, Korea, Republic of

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: June 16, 2016
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

KR (1)