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

Primary Purpose

Cardiac Output, Hypotension, Anesthesia, Spinal

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Isobaric marcaine
Hyperbaric marcaine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Output focused on measuring isobaric marcaine, hyperbaric marcaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isobaric Marcaine

Hyperbaric Marcaine

Arm Description

Isobaric Marcaine 2.2 mL for spinal block

Hyperbaric Marcaine 2.2 mL for spinal block

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total dose of vasopressor
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
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.

Full Information

First Posted
March 23, 2016
Last Updated
July 28, 2017
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02737813
Brief Title
Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section
Official Title
Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section: An Randomization Trials
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 29, 2016 (Actual)
Primary Completion Date
November 11, 2016 (Actual)
Study Completion Date
November 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Output, Hypotension, Anesthesia, Spinal
Keywords
isobaric marcaine, hyperbaric marcaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isobaric Marcaine
Arm Type
Experimental
Arm Description
Isobaric Marcaine 2.2 mL for spinal block
Arm Title
Hyperbaric Marcaine
Arm Type
Active Comparator
Arm Description
Hyperbaric Marcaine 2.2 mL for spinal block
Intervention Type
Drug
Intervention Name(s)
Isobaric marcaine
Other Intervention Name(s)
bupivacaine
Intervention Description
Isobaric marcaine 2.2 mL for spinal block
Intervention Type
Drug
Intervention Name(s)
Hyperbaric marcaine
Other Intervention Name(s)
bupivacaine
Intervention Description
Hyperbaric marcaine 2.2 mL for spinal block
Primary Outcome Measure Information:
Title
Change of cardiac output (L/min) after spinal block
Description
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 Outcome Measure Information:
Title
Total dose of vasopressor
Description
The investigators will record the total dose that treat hypotension during preoperative period
Time Frame
2 hours
Title
Number of patients who experience systolic blood pressure < 25% of preoperative measurement
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirilak Suksompong, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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

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