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

NCT02737813 | Completed Phase 4

• 1 other identifier: Marcaine
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Output; Hypotension; Anesthesia, Spinal

Keywords

isobaric marcaine; hyperbaric marcaine

Outcome Measures

Primary Outcomes (1)

• Change of cardiac output (L/min) after spinal block

  The investigators will measure cardiac output using non-invasive methods (USCOM) before spinal block and 5 minutes after spinal block.

  5 minutes after spinal block

Secondary Outcomes (2)

• Total dose of vasopressor

  2 hours

• Number of patients who experience systolic blood pressure < 25% of preoperative measurement

  2 hours

Study Arms (2)

Isobaric Marcaine

EXPERIMENTAL

Isobaric Marcaine 2.2 mL for spinal block

Drug: Isobaric marcaine

Hyperbaric Marcaine

ACTIVE COMPARATOR

Hyperbaric Marcaine 2.2 mL for spinal block

Drug: Hyperbaric marcaine

Interventions

Isobaric marcaine DRUG

Isobaric marcaine 2.2 mL for spinal block

Also known as: bupivacaine

Isobaric Marcaine

Hyperbaric marcaine DRUG

Hyperbaric marcaine 2.2 mL for spinal block

Also known as: bupivacaine

Hyperbaric Marcaine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Hypotension

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sirilak Suksompong, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 14, 2016
• Study Start: March 29, 2016
• Primary Completion: November 11, 2016
• Study Completion: November 15, 2016
• Last Updated: July 31, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)