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

Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section: An Randomization Trials

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02737813

Enrollment

168

Registered

2016-04-14

Start date

2016-03-29

Completion date

2016-11-15

Last updated

2017-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Spinal, Cardiac Output, Hypotension

Keywords

isobaric marcaine, hyperbaric marcaine

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

Interventions

DRUGIsobaric marcaine

Isobaric marcaine 2.2 mL for spinal block

DRUGHyperbaric marcaine

Hyperbaric marcaine 2.2 mL for spinal block

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of cardiac output (L/min) after spinal block	5 minutes after spinal block	The investigators will measure cardiac output using non-invasive methods (USCOM) before spinal block and 5 minutes after spinal block.

Secondary

Measure	Time frame	Description
Total dose of vasopressor	2 hours	The investigators will record the total dose that treat hypotension during preoperative period
Number of patients who experience systolic blood pressure < 25% of preoperative measurement	2 hours	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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026