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

Sponsors

Lead Sponsor: Seoul National University Hospital

Source 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.

Overall Status Completed
Start Date September 2015
Completion Date June 2016
Primary Completion Date May 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of hypotension events with treatment related during 30min after spinal anesthesia
Secondary Outcome
Measure Time Frame
total dose of phenylephrine during the surgery
Enrollment 72
Condition
Intervention

Intervention Type: Drug

Intervention Name: Bupivacaine

Description: spinal anesthesia with hyperbaric bupivacaine

Other Name: Heavy bupivacaine

Intervention Type: Drug

Intervention Name: Levobupivacaine

Description: spinal anesthesia with isobaric levobupivacaine

Other Name: chirocaine

Intervention Type: Drug

Intervention Name: Phenylephrine

Description: continous infusion of phenylephrine

Intervention Type: Drug

Intervention Name: normal saline

Description: continous infusion of normal saline

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

Gender: Female

Minimum Age: 19 Years

Maximum Age: 45 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Bahk Principal Investigator Seoul National University Hospital Seoul, Korea, Republic of
Location
Facility: Seoul National University Hospital
Location Countries

Korea, Republic of

Verification Date

July 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seoul National University Hospital

Investigator Full Name: Jae-Hyon Bahk, MD, PhD

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: "BUPI","P"

Type: Experimental

Description: patients who received hyperbaric bupivacaine and continous infusion of phenylephrine

Label: "BUPI","N"

Type: Placebo Comparator

Description: patients who received hyperbaric bupivacaine and continous infusion of normal saline

Label: "LEVO","P"

Type: Experimental

Description: patients who received isobaric levobupivacaine and continous infusion of phenylephrine

Label: "LEVO","N"

Type: Active Comparator

Description: patients who received isobaric levobupivacaine and continous infusion of normal saline

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov