Up-Down Determination of the ED90 of Metaraminol to Treat Hypotension During Cesarean Section

Federal University of São Paulo48 enrolled

Overview

The purpose of this study is to find the best dose of metaraminol to be used in patients during elective cesarean sections.

The purpose of this study is to determine the effective dose 90% (ED90) of metaraminol to treat hypotension after spinal anesthesia in elective cesarean sections (CS). It is a double-blind study that uses the biased-coin up-down sequential allocation method to determine the ED90 of metaraminol. Baseline systolic blood pressure (SBP) will be determined by three automated measures 3 minutes apart just before CS. During the period from induction of spinal anesthesia to fetal delivery SBP will be monitored every minute and metaraminol will be administered every time it is lower than baseline value. If SBP falls below 80% of baseline value, the treatment will be considered a failure. An adequate response will be defined as the absence of hypotension during the study period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypotension

Interventions

MetaraminolDRUG

Patients will be given metaraminol every time SBP falls below baseline value.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Elective CS under spinal anesthesia * Normal singleton pregnancy beyond 36 weeks gestation * ASA physical status I/II * Age over 18 years Exclusion Criteria: * Patient refusal * Allergy to metaraminol * Preexisting or pregnancy-induced hypertension * Cardiovascular or cerebrovascular disease * Fetal abnormalities

Locations (1)

Hospital São Paulo

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

The ED90 of Metaraminol to treat hypotension in elective cesarean section will be determined.

Bolus doses of metaraminol will be used every time SBP falls below baseline values and maternal responses to doses will be used to build a dose response curve from where ED90 will be estimated.

Time frame: From spinal induction until delivery (on average 30-60min)

Secondary Outcomes

Maternal Demographics (Age, Height, Weight and Gestational Age)

Incidence of Nausea and Vomiting

Time frame: From spinal induction until delivery (on average 30-60min)

Time between skin incision and delivery

Time between uterine incision and delivery

Total dose of metaraminol

Number of Participants with Hypertension or Bradycardia as a Measure of Safety and Tolerability

Time frame: From spinal induction until delivery (on average 30-60min)

Umbilical blood gases

Fetal well-being with Apgar scores

Data from ClinicalTrials.gov

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