- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00772616
Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption
Influence of Intraoperative Analgesia (Sufentanil Administered According to the Usual Criteria or Remifentanil Administered by a Closed-loop System Using Bispectral Index as the Controller) on the Postoperative Morphine Consumption
Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated bispectral index - guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. Both systems achieve the same objective: similar level of anesthesia indicated by bispectral index levels between 40 to 60. We make the assumption that this method of automated remifentanil administration may avoid postoperative hyperalgesia. Patients scheduled for abdominal surgery will be divided into two groups:
- in one group, patients will receive automatically delivered propofol and manually delivered sufentanil according to the usual criteria,
- in the other group, patients will receive propofol and remifentanil both automatically administered.
Assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Suresnes, Frankrig, 92150
- Hôpital Foch
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients scheduled for an abdominal surgery
Exclusion Criteria:
- Age less than 18 years,
- Pregnant women,
- Allergy to propofol, sufentanil, remifentanil, morphine, muscle relaxant, or to a component,
- Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
- Inflammatory bowel disease,
- Chronic pain,
- Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
- Alcoholic patients and patients taking opiates,
- History of neurological disorders or central brain lesion, of severe respiratory insufficiency, of hepatic insufficiency,
- Emergency surgery
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller).
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closed-loop administration using bispectral index as the single input for the controller.
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Aktiv komparator: 2
Patients will receive propofol automatically administered (closed-loop administration using bispectral index as the single input for the controller) and sufentanil according to usual criteria
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dosage according to usual criteria
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Dose of morphine administered during the postoperative period (patient controlled analgesia)
Tidsramme: 48 postoperative hours
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48 postoperative hours
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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postoperative pain scores
Tidsramme: 48 postoperative hours
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48 postoperative hours
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postoperative hyperalgesia
Tidsramme: up to 5th to 7th postoperative days
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up to 5th to 7th postoperative days
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nausea vomiting
Tidsramme: 48 postoperative hours
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48 postoperative hours
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
- Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2007/13
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