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CompletedNCT02737813Updated Jul 31, 2017

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

A Phase 4 interventional study of Isobaric marcaine and Hyperbaric marcaine in Cardiac Output, Hypotension and Anesthesia, Spinal, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-31.

Sponsored by Mahidol University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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

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Conditions studied

  • Cardiac Output
  • Hypotension
  • Anesthesia, Spinal

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Keywords

  • isobaric marcaine
  • hyperbaric marcaine
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In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 168 is above the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    Isobaric Marcaine

    Isobaric Marcaine 2.2 mL for spinal block

    Drug: Isobaric marcaine

  • Active comparator
    Hyperbaric Marcaine

    Hyperbaric Marcaine 2.2 mL for spinal block

    Drug: Hyperbaric marcaine

Interventions

  • DrugIsobaric marcaine

    Isobaric marcaine 2.2 mL for spinal block

    Also known as: bupivacaine

  • DrugHyperbaric marcaine

    Hyperbaric marcaine 2.2 mL for spinal block

    Also known as: bupivacaine

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What researchers measure

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.

    Time frame: 5 minutes after spinal block

Secondary outcomes

  1. Total dose of vasopressor

    The investigators will record the total dose that treat hypotension during preoperative period

    Time frame: 2 hours

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

    The investigators will monitor blood pressure at interval; before spinal block, then after spinal block every 1 minute for 10 for 10 times, every 2 minute for 5 times, every 3 minutes until delivery then every 5 minutes til the end of surgery. If the patient's systolic blood pressure is declined, vasopressor will be given.

    Time frame: 2 hours

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Study locations

1 site
  • Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
    Bangkok, 10700, Thailand
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02737813
Lead sponsor
Mahidol University
Responsible party
Sirilak Suksompong (Associate Professor, Mahidol University) — Principal investigator
First posted
Apr 14, 2016
Start date
Mar 29, 2016
Primary completion
Nov 11, 2016
Completion
Nov 15, 2016
Last update
Jul 31, 2017

Study contacts

Sirilak Suksompong, MD
principal investigator · Mahidol University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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