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Completed

NCT Number: NCT02737813

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

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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Key information

Conditions

Cardiac Output Anesthesia, Spinal Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isobaric marcaine

Drug

Isobaric marcaine 2.2 mL for spinal block

Other names: bupivacaine

Hyperbaric marcaine

Drug

Hyperbaric marcaine 2.2 mL for spinal block

Other names: bupivacaine

Primary outcomes

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

    Time frame: 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 outcomes

  1. Total dose of vasopressor

    Time frame: 2 hours

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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2016
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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