Influence of continuous administration of phenylephrine versus dobutamine on spinal oxygen saturation, measured with near-infrared spectroscopy (NIRS).
Phase 1
- Conditions
- spinal vasculaturespinal oxygen saturationmuscle oxygen saturationcerebral oxygen saturationTherapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2018-003687-31-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 34
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
•Age < 18y
•, BMI > 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>Relationship between NIRS and MAP and CO.<br>Influence of sympathetic stimulation (during intubation) on cerebral and spinal and muscle oxygen saturation.<br>;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.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Cerebral and Deltoid muscle oxygen saturation <br>;Timepoint(s) of evaluation of this end point: From awake (supine) position (= baseline) until 30 min after start of administration of study drug.<br>