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Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section

NCT ID: NCT02737813

Last Updated: 2017-07-31

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

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-29

Study Completion Date

2016-11-15

Brief Summary

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Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher cardiac output than those who received phenylephrine

Detailed Description

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Conditions

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Cardiac Output Hypotension Anesthesia, Spinal

Keywords

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isobaric marcaine hyperbaric marcaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Isobaric Marcaine

Isobaric Marcaine 2.2 mL for spinal block

Group Type EXPERIMENTAL

Isobaric marcaine

Intervention Type DRUG

Isobaric marcaine 2.2 mL for spinal block

Hyperbaric Marcaine

Hyperbaric Marcaine 2.2 mL for spinal block

Group Type ACTIVE_COMPARATOR

Hyperbaric marcaine

Intervention Type DRUG

Hyperbaric marcaine 2.2 mL for spinal block

Interventions

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Isobaric marcaine

Isobaric marcaine 2.2 mL for spinal block

Intervention Type DRUG

Hyperbaric marcaine

Hyperbaric marcaine 2.2 mL for spinal block

Intervention Type DRUG

Other Intervention Names

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bupivacaine bupivacaine

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiology classification I - II
* Elective or urgency Cesarean section with spinal block e.g. cephalopelvic disproportion, premature rupture of membrane
* Singleton pregnancy
* Body mass index \< 40 kg/m2

Exclusion Criteria

* Pregnancy \<35 weeks gestational age
* Hypertensive disease e.g. gestational hypertension, chronic hypertension, preeclampsia
* History of allergy to the study drugs
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Sirilak Suksompong

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sirilak Suksompong, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Marcaine

Identifier Type: -

Identifier Source: org_study_id