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Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain

24. marts 2011 opdateret af: First Affiliated Hospital, Sun Yat-Sen University

Effects of Parecoxib on Emergence Delirium and Postoperative Pain in Elderly Patients Undergoing Abdominal Surgery After General Anesthesia

This prospective, double blind, placebo-controlled, parallel group study will be conducted in three study centers in Guangzhou, China. Patients aged older than 65 (ASA I-III) undergoing primary elective abdominal surgery with general anesthesia will be involved in this study. According to previous studies and our pilot trial, the sample size was estimated to be 900 subjects (each center recruiting 300 patients). All eligible patients will be randomly assigned to one of two groups: study group receiving parecoxib and control group receiving normal saline. All patients will be managed with by a standard clinical anesthesia protocol with a sevoflurane-based general anesthesia with continuous intravenous remifentanil, followed by a postoperative PCA with morphine. The emergence delirium will be evaluated by two persons blinding to medication and grouping using Riker sedation-agitation scale immediately since tracheal extubation and at specific time points until patients being discharged from PACU. Pain intensity assessments and pain relief assessments will also be conducted by the patients at given time points in 2 days postoperatively. The morphine-sparing effect, tolerability and safety of parecoxib will be investigated as well.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The inclusion criteria of this study includes:

  • Aged older than 65;
  • Primary elective abdominal surgery under general anesthesia;
  • Ability to understand how to use pain assessment scales and PCA device.

The outcome measures of this study includes:

  • Emergence Delirium Assessment;
  • Pain intensity and pain relief efficacy endpoints;
  • Tolerability and Safety Assessments

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

900

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • Rekruttering
        • The First Affiliated Hospital of Sun Yat-sen University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 90 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Aged older than 65;
  • Body weight of at least 50 kg;
  • Primary elective abdominal surgery under general anesthesia;
  • Preoperative health graded as class ASA I-III, based on medical history and physical examination;
  • Ability to understand how to use pain assessment scales and PCA device

Exclusion Criteria:

  • Emergency or revised abdominal surgery;
  • History of known use of analgesics or any other agent that could interfere with analgesic responses during the up to 24 h before receipt of the study medication which including NSAIDs, tricyclic antidepressants, neuroleptic or antipsychotic agents, or corticosteroids (except routine preoperative medication);
  • History of known or suspected drug abuse;
  • Known allergy, sensitivity, or contraindication to opioid and non-opioid analgesic drugs;
  • History of bleeding disorders, peptic ulceration, or anticoagulant use within the past month;
  • History of asthma or bronchospasm;
  • History of inflammatory bowel disease, a chronic or acute renal or hepatic disorder, coronary heart disease;
  • History of dementia and psychological disorder;
  • Contraindication to parecoxib.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: parecoxib
Parecoxib, a water-soluble prodrug of valdecoxib, is a high-selective COX-2 inhibitor that is first available for intravenous administration.
Medicin: Parecoxib
The study group will receive first dose of intravenous (IV) injection of parecoxib sodium 40 mg (in a volume of 2 ml) 60 min before the anticipated end of surgery, followed 2 ml IV injection of parecoxib 40 mg will be occurred at 12, 24 and 36 h after the first dose of parecoxib.
Andre navne:
  • Brand name: Dynastat

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
emergence agitation
Tidsramme: 45 min after anesthesia
the incidence of emergence agitation after recovery from general anesthesia before discharging from PACU
45 min after anesthesia

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The amount of morphine consumption and Pain intensity
Tidsramme: 48h postoperatively
The amount of morphine consumption from PCA pump at PACU, 12, 24, 36, and 48h after first dose of study medication; Pain intensity (NRS scores) at 2, 4, 6, 9, 12, 18, 24, 36 and 48 h after the first dose of study medication.
48h postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Samarbejdspartnere

Pfizer

Efterforskere

  • Ledende efterforsker: Haihua Shu, MD; Ph D, First Affiliated Hospital, Sun Yat-Sen University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2010

Primær færdiggørelse (Forventet)

1. december 2011

Studieafslutning (Forventet)

1. juni 2012

Datoer for studieregistrering

Først indsendt

12. oktober 2010

Først indsendt, der opfyldte QC-kriterier

13. oktober 2010

Først opslået (Skøn)

14. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. marts 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2011

Sidst verificeret

1. oktober 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SHHparecoxib1

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Postoperativ smerte

Kliniske forsøg med Parecoxib

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Sponsorer og samarbejdspartnere

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CROs in Kenya

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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