- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00436345
Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)
25 maggio 2017 aggiornato da: GlaxoSmithKline
A Randomized, Open Label, Multicentre Study to Compare the Pharmaco-economic Implications of an Analgesia Based Regimen With Remifentanil and a Conventional Sedation Based Regimen Using Propofol in Medical and Post-surgical ICU Subjects Requiring Mechanical Ventilation for at Least 2 Days.
This study will be a multicentre randomized, open-label, phase IIIb study.
This study will evaluate two different techniques of sedation: an analgesia based regimen with remifentanil versus a conventional sedation based regimen using propofol in subjects that require mechanical ventilation for at least 2 days in the ICU.
The conventional sedation based regimen will consist of propofol combined with an opioid according to routine clinical practice (morphine, fentanyl, sufentanil or other as required) .
The analgesia based regimen will consist of remifentanil, with propofol added on if required.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
39
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Calabria
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Catanzaro, Calabria, Italia, 88100
- GSK Investigational Site
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Campania
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Napoli, Campania, Italia, 80131
- GSK Investigational Site
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Emilia-Romagna
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Ferrara, Emilia-Romagna, Italia, 44100
- GSK Investigational Site
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Friuli-Venezia-Giulia
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Udine, Friuli-Venezia-Giulia, Italia, 33100
- GSK Investigational Site
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Lazio
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Roma, Lazio, Italia, 00161
- GSK Investigational Site
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Sicilia
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Palermo, Sicilia, Italia, 90127
- GSK Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
- Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
- Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid.
Exclusion Criteria:
- Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
- Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided
Concurrent medications:
- Requires or is likely to require neuromuscular blocking agents by continuous infusion to facilitate mechanical ventilation
- Has or is likely to receive an epidural block during the treatment period
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Propofol
Infusione di propofol
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conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical
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Sperimentale: Remifentanil
remifentanil
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analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
Lasso di tempo: Up to 38 days (912 hours)
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Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).
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Up to 38 days (912 hours)
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Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)
Lasso di tempo: Up to 38 days (912 hours)
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Time from start of mechanical ventilation until actual extubation.
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Up to 38 days (912 hours)
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Duration of Time on Mechanical Ventilation (Per-Protocol Population)
Lasso di tempo: Up to 38 days (912 hours)
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Time from start of mechanical ventilation until actual extubation
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Up to 38 days (912 hours)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator's Decision)
Lasso di tempo: Up to 38 days (912 hours)
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Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.
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Up to 38 days (912 hours)
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Duration of Extubation
Lasso di tempo: up to 38 days (912 hours)
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Duration of extubation was measured.
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up to 38 days (912 hours)
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Duration of Weaning
Lasso di tempo: up to 38 days (912 hours)
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Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.
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up to 38 days (912 hours)
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Duration of Remifentanil Infusion (ITT Population)
Lasso di tempo: Up to 10 days (240 hours)
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Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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Up to 10 days (240 hours)
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Duration of Propofol Infusion (ITT Population)
Lasso di tempo: up to 10 days (240 hours)
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Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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up to 10 days (240 hours)
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Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)
Lasso di tempo: up to 10 days (240 hours)
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Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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up to 10 days (240 hours)
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Dose of Remifentanil Administered - Continuous Infusion
Lasso di tempo: Up to 10 days
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Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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Up to 10 days
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Doses of Sufentanil and Fentanil Administered - Continuous Infusion
Lasso di tempo: up to 10 days
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Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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up to 10 days
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Dose of Propofol Administered - Continuous Infusion
Lasso di tempo: Up to 10 days
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Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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Up to 10 days
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Dose of Morphine Administered - Continuous Infusion
Lasso di tempo: up to 10 days
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Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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up to 10 days
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Total Dose of Propofol Administered - Bolus
Lasso di tempo: Up to 10 days
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Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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Up to 10 days
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Total Dose of Fentanil Administered - Bolus
Lasso di tempo: Up to 10 days
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Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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Up to 10 days
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Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale
Lasso di tempo: Up to 38 Days
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Data from participants in the study for which the Sedation-Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed.
"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
"Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
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Up to 38 Days
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Sedation-Agitation From Screening Through the End of Study
Lasso di tempo: Up to 38 days
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"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
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Up to 38 days
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Sedation-Agitation for Day 7
Lasso di tempo: Day 7
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"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
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Day 7
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Sedation-Agitation From Day 8 to Day 10
Lasso di tempo: Days 8, 9, and 10
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"Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
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Days 8, 9, and 10
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Number of Participants Analyzed for BIS (Bispectral Index Scale)
Lasso di tempo: Up to 38 days
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Participants in the study for which BIS were evaluated.
The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100.
A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
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Up to 38 days
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Bispectral Index (BIS)
Lasso di tempo: Screening through End of Study, up to 38 days
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The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100.
A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
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Screening through End of Study, up to 38 days
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Bispectral Index (BIS) for Day 5
Lasso di tempo: Day 5
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The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100.
A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
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Day 5
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Bispectral Index (BIS) for Extubation Period and Post-Extubation Period
Lasso di tempo: up to 38 days
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The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100.
A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
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up to 38 days
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Pain Intensity (PI)
Lasso di tempo: Up to 38 days
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"Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
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Up to 38 days
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Pain Intensity From Day 8 to Day 10
Lasso di tempo: Days 8, 9, and 10
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"Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
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Days 8, 9, and 10
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2007
Completamento primario (Effettivo)
1 agosto 2008
Completamento dello studio (Effettivo)
1 settembre 2008
Date di iscrizione allo studio
Primo inviato
15 febbraio 2007
Primo inviato che soddisfa i criteri di controllo qualità
15 febbraio 2007
Primo Inserito (Stima)
19 febbraio 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 maggio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 maggio 2017
Ultimo verificato
1 maggio 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Manifestazioni neurologiche
- Manifestazioni neurocomportamentali
- Disturbi percettivi
- Agnosi
- Effetti fisiologici delle droghe
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Anestetici, per via endovenosa
- Anestetici, Generale
- Anestetici
- Analgesici, oppioidi
- Narcotici
- Ipnotici e sedativi
- Remifentanil
- Propofol
Altri numeri di identificazione dello studio
- 108701
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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