Influence of a bolus administration of ephedrine and phenylephrine on the spinal oximetry.

Influence of a bolus administration of ephedrine and phenylephrine on spinal oxygen saturation, measured with NIRS. - Influence of a bolus administration of ephedrine and phenylephrine on the spinal oximetry.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001839-13-BE

Enrollment

Registered

2016-05-12

Start date

2016-06-07

Completion date

Unknown

Last updated

2018-12-10

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

Conditions

Hypotension during surgery Paraplegia and/or paraparesis

Interventions

Trade Name: Ephedrine HCl Aguettant 3 mg/ml oplossing voor injectie in een voorgevulde spuit Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: EPHEDRINE HYDROCHLOR

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients > 18y, scheduled for dilation of arterial blood vessels of the lower limb. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: Age 30; severe valvular disease; previous aortic surgery; paraplegia/ paraparesis

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the effect of vasoactive agents (ephedrine and phenylephrine) on the spinal vasculature by measuring spinal oxygenation, using near infrared spectroscopy in peripheral vascular surgery.;Secondary Objective: Power analysis and sample size calculation for further research Relationship NIRS - MAP ;Primary end point(s): Spinal oxygen saturation measured by NIRS;Timepoint(s) of evaluation of this end point: During surgery	—

Measure

Time frame

Main Objective: Evaluation of the effect of vasoactive agents (ephedrine and phenylephrine) on the spinal vasculature by measuring spinal oxygenation, using near infrared spectroscopy in peripheral vascular surgery.;Secondary Objective: Power analysis and sample size calculation for further research Relationship NIRS - MAP ;Primary end point(s): Spinal oxygen saturation measured by NIRS;Timepoint(s) of evaluation of this end point: During surgery

—

Secondary

Measure	Time frame
Secondary end point(s): Heartrate Blood pressure Cerebral oxygenation (NIRS) Total amount of vasoactive medication used ;Timepoint(s) of evaluation of this end point: Continue after induction of anesthesia	—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

bimetra.clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026