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Phenylephrine to prevent pressure drop in obese pregnant women who underwent cesarean section

Phenylephrine infusion to prevent arterial hypotension in Obese pregnant women undergoing cesarean section under spinal anesthesia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-42dch5
Enrollment
Unknown
Registered
2020-05-08
Start date
2018-06-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Interventions

In the operating room, every patient will be monitored with pulse oximetry, continuous electrocardioscopy and non-invasive blood pressure throughout the anesthetic-surgical procedure. And you will rec
Group F 100: Phenylephrine 100 mcg / min (0.1 mg / mL) or in Group C: saline. All solutions will be administered using a volumetric infusion pump from Samtronic®, at a rate of 60 ml / h until fetal ex
Drug

Sponsors

Hospital Universitário Júlio Muller
Lead Sponsor
Hospital Universitário Júlio Muller
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Obese pregnant women with a body mass index greater than or equal to 30 Kg / m2 candidates for elective cesarean section under spinal anesthesia, classified in Physical State II to III of the American Society of Anesthesiologists (ASA) who sign the written, free and informed consent.

Exclusion criteria

Exclusion criteria: Age less than 18 years; gestational age less than 37 weeks; hypertensive pregnancy disease, defined as systolic blood pressure (SBP) greater than 140 mmHg or diastolic blood pressure (DBP) greater than 90 mmHg; twinning; intrauterine growth retardation; cardiovascular disease class II above the New York Heart Association; cerebrovascular disease, fetal abnormality and contraindications to spinal anesthesia (e.g., hemodynamic instability, infection at the lumbar puncture site, coagulopathy and spinal neurological disease).

Design outcomes

Primary

MeasureTime frame
It is expected to find a 50% reduction in hypotension episodes in patients who receive intravenous phenylephrine infusion.

Secondary

MeasureTime frame
40% reduction in nausea and vomiting episodes in patients with phenylephrine infusion.

Countries

Brazil

Contacts

Public ContactLuis Fernando Martins

Hospital Universitário Júlio Muller

drlfmartins@globo.com+55 065 99968-9616

Outcome results

None listed

Source: REBEC (via WHO ICTRP)