MedTrace Logo

Influence of a Bolus Administration of Ephedrine and Phenylephrine on the Spinal Oxygen Saturation, Measured With NIRS.

NCT03767296 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-12-07

No results posted yet for this study

Summary

To evaluate the influence of vasoactive medication on the spinal vasculature, we have chosen patients scheduled for arterial dilation of the lower limb as our study population. In these patients the spinal cord perfusion is not compromised. However, most patients will suffer from hypotension during surgery, due to the non-invasive type of surgery and the vasodilating effects of the anesthetics. Therefore, bolus administration of vasoactive medication (ephedrine, phenylephrine) is routinely required in order to increase the blood pressure.

The aim of the study is to observe the influence of a bolus administration of ephedrine and phenylephrine on the spinal vasculature, measured by NIRS.

Conditions

  • Influence of Vasoactive Medication on Spinal Oxygenation

Interventions

DRUG

Ephedrine Hydrochloride 3 MG/ML

Bolus group, according to the randomization. Multiple boluses with incremental doses might be needed, according to the MAP ('effect titration') Incremental doses if needed: Ephedrine (E): 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) A total amount of 140 mg Ephedrine will not be exceeded. Titrated according to the desired effect (= MAP decrease \< 20%)

DRUG

Phenylephrine

Bolus group, according to the randomization. Multiple boluses with incremental doses might be needed, according to the MAP ('effect titration') Incremental doses if needed: Phenylephrine (PE): 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) A total amount of 1500 μg will not be exceeded. Titrated according to the desired effect (= MAP decrease \< 20%)

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Caroline Vanpeteghem · UZ Ghent

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2017-09-09
Completion
2018-12-04

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT03767296 on ClinicalTrials.gov