Primary goal of this study is to quantify changes in systolic and diastolic blood pressure, heart rate and pO2 before and after i.v. administration of either IOCM or LOCM. In particular the occurrence of clinically relevant drops in systolic and diastolic blood pressure after IOCM or LOCM administration is investigated.
Conditions
Interventions
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Pharmaceutical F
Sponsors
Innsbruck Medical University, Department of Radiology, Section of Microinvasive Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Primary or secondary liver tumors treatable by SRFA. • Approval of an interdisciplinary cancer board for SRFA. • Adult patients > 18 years, American Society of Anesthesiologists (ASA) score I-III, scheduled for radiological interventions with CM (obligate application) under general anesthesia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Reduced mental status of the patient, history of psychiatric disorder, refusal by patient, failure to obtain written and informed consent. • Primary or secondary liver tumors larger than 12 cm in diameter or prediction of insufficient liver remnant, more than 7 lesions, lesions within 1 cm distance to the central bile duct, lesions infiltrating adjacent hollow viscera. • Liver cirrhosis classified higher than Child-Pugh class B, manifest ascites. • Estimated glomerular filtration rate (eGFR) 50 sec and thrombocytes < 50,000/mm3) or recent intake of platelet aggregation inhibitors • Evidence of intolerance or allergic reactions against both CM. • Contraindications to both CM according to Austrian Fachinformation • Antihypertensive treatment except Midazolam (Dormicum®, Roche Pharmaceutics, Vienna, Austria) orally 30 minutes prior to surgery at dose between 3.75 and 7.5 mg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary goal of this study is to quantify changes in systolic and diastolic blood pressure, heart rate and pO2 before and after i.v. administration of either IOCM or LOCM. In particular the occurrence of clinically relevant drops in systolic and diastolic blood pressure after IOCM or LOCM administration is investigated. ;Secondary Objective: Secondary goal is to evaluate potential differences in changes in systolic and diastolic blood pressure, heart rate and pO2 before and after i.v. administration of CM (either LOCM or IOCM) or the equal amount of normo-saline solution.;Primary end point(s): Primary study endpoint of this study is to quantify changes in systolic and diastolic blood pres-sure, heart rate and pO2 before and after i.v. administration of either IOCM or LOCM. In particular the occurrence of clinically relevant drops in systolic and diastolic blood pressure after IOCM or LOCM administration is investigated. ;Timepoint(s) of evaluation of this end point: 1: End of induction of general anesthesia and positioning of the patient (=baseline) and the lowest value measured within 3 minutes after 2: Planning CT after i.v. administration of CM., 3: Control CT 1 (needle placement) after i.v. administration of normo-saline solution (same amount and injection rate as in step 2), and 4: Control CT 2 (ablation size) after i.v. administration of CM (same CM, amount and injection rate as in step 2). The interval to return of baseline blood pressure is recorded and the mean duration calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint is to evaluate potential differences in changes in systolic and diastolic blood pressure before and after i.v. administration of CM (either LOCM or IOCM) or the equal amount of normo-saline solution.;Timepoint(s) of evaluation of this end point: 48 hrs | — |
Countries
Austria
Contacts
Public ContactInvestigator
Innsbruck Medical University, Department of Radiology, Section of Microinvasive Therapy
Outcome results
None listed