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

Phase 4

Completed

• Conditions: Anesthesia, Spinal; Hypotension; Cardiac Output
• Interventions: Drug: Isobaric marcaine; Drug: Hyperbaric marcaine

• Registration Number: NCT02737813
• Lead Sponsor: 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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-03-23
• Study Start: 2016-03-29
• Study First Submitted QC: 2016-04-09
• Study First Posted: 2016-04-14
• Primary Completion: 2016-11-11
• Study Completion: 2016-11-15
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-28
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isobaric Marcaine	Isobaric marcaine	Isobaric Marcaine 2.2 mL for spinal block
Hyperbaric Marcaine	Hyperbaric marcaine	Hyperbaric Marcaine 2.2 mL for spinal block

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand