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Norepinephrine ED90 Bolus After Spinal Anesthesia in Cesarean Section

NCT06574555 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-29

No results posted yet for this study

Summary

The investigators are aiming to determine what is the effective intravenous dose required of an initial bolus of norepinephrine prior to a maintenance infusion to prevent a 20% decrease in maternal blood pressure from baseline following the administration of spinal anesthesia for elective cesarean section in healthy parturients

Conditions

Interventions

DRUG

Norepinephrine

The outcome of patient n in each sequence will determine the dose to be allocated patient n+1. Successive doses will be determined with the up-and-down k-in-row design method for ED90 determination: * Failure: the dose should be increased in one level (+0.02 µg/kg) after failure to respond (arterial hypotension); * Success: decrease in one level (-0.02 µg/kg) upon successful response (no arterial hypotension), but only after observing at least k-consecutive positive responses at the same dose (in this case, k=7); otherwise, remain at the same dose. This will be done until each sequence completes n=30.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Ivonne Vargas Celis, MD · Presidente, Comité Ético Científico Salud de la Universidad Católica

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-08-01
Completion
2025-08-02

Countries

  • Chile

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06574555 on ClinicalTrials.gov