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

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

Study Overview

• Status: Completed
• Conditions: Hypotension; Cardiac Output; Anesthesia, Spinal
• Intervention / Treatment: Drug: Isobaric marcaine; Drug: Hyperbaric marcaine

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 minutes after spinal block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dose of vasopressor	The investigators will record the total dose that treat hypotension during preoperative period	2 hours
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.	2 hours

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2016
• Primary Completion (Actual): November 11, 2016
• Study Completion (Actual): November 15, 2016

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 9, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: isobaric marcaine; hyperbaric marcaine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Marcaine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No