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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Hypotension; Cardiac Output; Anesthesia, Spinal

Treatments: Drug: Hyperbaric marcaine; Drug: Isobaric marcaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02737813

Marcaine

Details and patient eligibility

About

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

Enrollment: 168 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 2 patient groups

Isobaric Marcaine

Experimental group

Description:

Isobaric Marcaine 2.2 mL for spinal block

Treatment:

Drug: Isobaric marcaine

Hyperbaric Marcaine

Active Comparator group

Description:

Hyperbaric Marcaine 2.2 mL for spinal block

Treatment:

Drug: Hyperbaric marcaine