Influence of continuous administration of phenylephrine versus dobutamine on spinal oxygen saturation, measured with near-infrared spectroscopy (NIRS).

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003687-31-BE

Enrollment

Registered

2018-12-11

Start date

2019-01-31

Completion date

Unknown

Last updated

2021-07-21

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

Conditions

spinal vasculature spinal oxygen saturation muscle oxygen saturation cerebral oxygen saturation

Interventions

Trade Name: Phenylephrine Unimedic 10 mg/ml, concentrate for solution for Injection/Infusion Product Name: Phenylephrine Unimedic 10 mg/ml, concentrate for solution for Injection/Infusion Pharmaceutic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients = 18y • Patient is, 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 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23

Exclusion criteria

Exclusion criteria: • Age 30, • severe valvular disease, • previous aortic surgery, • paraplegia/ paraparesis, • kidney replacement therapy, • pacemaker, • pregnancy, • preoperative use of ACE inhibitors. • No sinus rhythm on preoperative ECG or at induction of anesthesia (patients with a history of atrial fibrillation can be included if they have a sinus rhythm on their preoperative ECG)

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the effect of continuous administration of phenylephrine or dobutamine on the spinal vasculature, by measuring spinal oxygen saturation with NIRS. ;Secondary Objective: Relationship between cerebral oxygen saturation, muscle saturation and the type of hemodynamic support provided. Relationship between NIRS and MAP and CO. Influence of sympathetic stimulation (during intubation) on cerebral and spinal and muscle oxygen saturation. ;Primary end point(s): Spinal oxygen saturation measured by NIRS;Timepoint(s) of evaluation of this end point: From awake (supine) position (= baseline) until 30 min after start of administration of study drug.	—

Measure

Time frame

Main Objective: Evaluation of the effect of continuous administration of phenylephrine or dobutamine on the spinal vasculature, by measuring spinal oxygen saturation with NIRS. ;Secondary Objective: Relationship between cerebral oxygen saturation, muscle saturation and the type of hemodynamic support provided. Relationship between NIRS and MAP and CO. Influence of sympathetic stimulation (during intubation) on cerebral and spinal and muscle oxygen saturation. ;Primary end point(s): Spinal oxygen saturation measured by NIRS;Timepoint(s) of evaluation of this end point: From awake (supine) position (= baseline) until 30 min after start of administration of study drug.

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Secondary

Measure	Time frame
Secondary end point(s): Cerebral and Deltoid muscle oxygen saturation ;Timepoint(s) of evaluation of this end point: From awake (supine) position (= baseline) until 30 min after start of administration of study drug.	—

Countries

Belgium

Contacts

Public ContactHIRUZ

Ghent University Hospital

hiruz.ctu@uzgent.be+3293320500

Outcome results

None listed

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