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

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ClinicalTrials.gov Identifier: NCT02737813
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University

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

Condition or disease Intervention/treatment Phase
Cardiac Output Hypotension Anesthesia, Spinal Drug: Isobaric marcaine Drug: Hyperbaric marcaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section: An Randomization Trials
Actual Study Start Date : March 29, 2016
Actual Primary Completion Date : November 11, 2016
Actual Study Completion Date : November 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Isobaric Marcaine
Isobaric Marcaine 2.2 mL for spinal block
Drug: Isobaric marcaine
Isobaric marcaine 2.2 mL for spinal block
Other Name: bupivacaine

Active Comparator: Hyperbaric Marcaine
Hyperbaric Marcaine 2.2 mL for spinal block
Drug: Hyperbaric marcaine
Hyperbaric marcaine 2.2 mL for spinal block
Other Name: bupivacaine




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737813


Locations
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Thailand
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Sirilak Suksompong, MD Mahidol University

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Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02737813     History of Changes
Other Study ID Numbers: Marcaine
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Sirilak Suksompong, Mahidol University:
isobaric marcaine
hyperbaric marcaine
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents