E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypotension during general anaesthesia or central blockades |
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E.1.1.1 | Medical condition in easily understood language |
Low blood pressure during surgery |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study side effects of peripheral administration of norepinephrine. |
Primärt utfallsmått är andel komplikationer av noradrenalin administrerat i perifer venkateter. |
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E.2.2 | Secondary objectives of the trial |
Secondary objective is to study if the localisation of the peripheral venous catheter, the duration of the infusion or comorbidity are associated with higher complication rate. |
Sekundära mål är att studera om sjuklighet (mätt som ASA-klass och samsjuklighet), placering av venkateter (arm, hand, fot) eller duration av infusion är associerat med högre andel komplikationer. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients aged 18 years or above who undergo general anaesthesia or central blockades in the operation theater with hypotension and need of vasopressor support can be included. |
Patienter ≥18 år som genomgår generell anestesi och/ eller erhåller centrala blockader vid operationsavdelning med blodtryckssänkning som följd och därigenom behov av vasopressorstöd, kan inkluderas. |
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E.4 | Principal exclusion criteria |
Lack of consent. The patient has a central venous catheter in place. |
Patienten samtycker inte till medverkan. Patienten har en central venös infart. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of adverse events and serious adverse events. We will study inadverent subcutaneous infusion, white colouring of the skin and hypertension (systolic blood pressure>220 mmHg) and skin necrosis |
Primärt utfallsmått är andel komplikationer av noradrenalin administrerat i perifer venkateter. De komplikationer som vi studerar är subkutan infusion/vithet/blekhet vid venkatetern samt högt blodtryck (systoliskt blodtryck>220 mmHg) ochhud nekros. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the study period, maximum length 72 hours. |
Under studieperioden, maximalt 72 timmar. |
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E.5.2 | Secondary end point(s) |
Secondary aims are to evaluate if comorbidity, the localisation of the peripheral venous catheter or the duration of infusion is associated with higher incidence of complications. |
Sekundära mål är att studera om sjuklighet (mätt som ASA-klass och samsjuklighet), placering av venkateter (arm, hand, fot) eller duration av infusion är associerat med högre andel komplikationer. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During the study period, maximum 72hours. |
Under studieperioden, maximalt 72 timmar. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
öppen, okontrollerad interventionsstudie |
An open, uncontrolled interventional study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |