E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anaesthesia and recovery in cardiac surgery patients. |
Anæstesi og opvågningsforløb hos patienter der gennemgår hjertekirurgisk indgreb |
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E.1.1.1 | Medical condition in easily understood language |
Patient submitted for cardiac surgery. The drugs is basis for different type of anaesthesia |
Patienter der skal gennemgå hjertekirurgisk indgreb. Medikamenter er basis i to typer anæstesi |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021722 |
E.1.2 | Term | Induction and maintenance anaesthesia |
E.1.2 | System Organ Class | 100000004865 |
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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 |
Stress, anxiety and type A personality and analgesic requirements.
Level of anaesthesia using BIS and EEG monitoring, haemodynamic effexts and quality of recovery
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Stress, anxiety and type A personality and analgesics (quality insurance project).
Niveau af smertestillende midler ved anæstesi til hjertekirurgi bedømt BIS, EEG monitorering, hæmodynamiske effekter (PAC/ekkokardiografi) samt opvågningsforløb (ICU Discharge Score)
At vurdere effekten af standard opioider (Sufentanyl og Morfin) ved hjertekirurgi ved forskellige typer af stress, angst og type A personality bedømt ved:
1) Hastighed og mængde til opnåelse af søvndybde target-point ved bispektral index monitorering (BIS).
2) Hastighed og mængde til opnåelse af target-point ved EEG
3) Evaluere opvågningsforløb bedømt ved ventilationstid, tid på hjerteopvågning, udvalgte kvalitetsparametre i opvågningsfasen samt ICU-discharge score (IDS) i relation til præoperative tests og peroperative opioider
4) Perioperative hæmodynamiske effekter bedømt med pulmonalt arteriekateter (PAC) og ekkokardiografi. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients for cardiac surgery |
Alle patienter der skal gennemgå hjertekirurgisk indgreb |
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E.4 | Principal exclusion criteria |
Patients requiring special anaesthesia or critical preoperative state
Patients expected to have long ventilation time and long time in ICU |
1.Patienter der af en eller anden grund kræver særlig anæstesiindledning eller monitorering på grund af præ-operativ kritisk tilstand.
2.Patienter der forventes at have længere ventilationstid eller behov for længerevarende ophold på intensiv afdeling
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E.5 End points |
E.5.1 | Primary end point(s) |
Equivalent doses of analgesics to obtain anaesthetic level
Effect on ICU score
End points correlated to preoperative stress and anxiety tests |
Primære endepunkter:
1) Ækvivalent opioid dosis samt tid til opnåelse af BIS 55-60
2) IDScore (herunder opvågningskvalitet)
End-points korreleres til præoperative psykologiske tests. Primære opioid er Sufentanyl
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of recovery |
Afslutning af opvågningsfasen |
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E.5.2 | Secondary end point(s) |
Difference in ventilation time
Difference in quality of recovery
Haemodynamic effect of drugs |
Sekundære endepunkter:
1. Ventilationstid
2. Forskel i forbrug og opvågningsforløb mellem Sufentanyl og Morfin
3.Hæmodynamiske effekt Invasive hæmodynamiske mål ved PAC: Cardiac Index (CI), systemisk modstand (SVRI), systemiske blodtryk (SAP, DAP, MAP), blodtryk i pulmonalkredsløb (mPAP), blandet venøs saturation (SvO2), pH, laktat.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of recovery |
Slutning af opvågningsfasen |
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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 | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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 | |