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Blood Propofol Concentrations in Children During Spinal Surgery

Comparison of Measured Versus Predicted Blood Propofol Concentrations During Total Intravenous Anaesthesia in Children Undergoing Spinal Surgery

During major spinal surgery evoked potential monitoring is performed to detect spinal cord damage. Intra-venous anaesthesia is the preferred anaesthetic technique because volatile anaesthetic agents supress the evoked potentials. Total Intra-Venous Anaesthesia (TIVA) with propofol is commonly administered as a Target Controlled Infusion (TCI). The TCI is an automated drug delivery system which administers propofol to achieve a desired blood concentration, based on an in built pharmaco-kinetic data (TCI model) derived from previous studies. The TCI model also provides a real time predicted blood concentration to facilitate the anaesthetist to adjust the target concentration of propofol.

The TCI algorithm is based on pharmaco-kinetic data derived from previous studies in a relatively small number of patients, by a "best fit" relationship between blood levels, infusion rates and other factors (such as age and weight). Several factors make it possible for a wide discrepancy between the predicted and the true blood concentrations. This difference can be higher in children compared to adults. Also blood loss and administration of large volumes of intravenous fluids can affect the blood concentrations. This study aims to identify the difference between the predicted and true blood concentrations by using Pelorus 1500, a bedside blood propofol measurement device, in children undergoing major spinal surgery under TIVA.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

20

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • London, Storbritannia, WC1N 3JH
        • Great Ormond Street Hospital for Children NHS Trust

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Children undergoing major spinal surgery under propofol TCI
  • Surgery expecting to last more than 3 hours.

Exclusion Criteria:

  • Major hepatic or renal disease

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Single arm
The intervention in this study involves taking blood sample from an existing arterial line for measurement of blood propofol levels. The drug in evaluation is Propofol 2% (Diprivan 2%, Astra Zeneca UK) administered as a target controlled infusion using the commercially available paediatric TCI models (Paedfusor and Marsh models). The dose range is usually between a target concentration of 3-8 mcg/ml. However the anaesthetic management is not changed for the study. The blood concentrations of propofol will be measured using Pelorus 1500 (Sphere Medical, UK), a CE marked device. The anaesthetist will be blinded from the measurements, unless the measured value was outside the safe limit ( < 3 mcg/ml or > 10mcg/ml).
a bedside blood propofol measurement device
Andre navn:
  • Sphere Medical, UK

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
The absolute difference between the measured and predicted concentrations of propofol in micrograms per ml of blood.
Tidsramme: Up to 5 hours during the maintenance phase of anaesthesia, to allow a maximum of 10 samples at 20 to 30 min intervals.
Up to 5 hours during the maintenance phase of anaesthesia, to allow a maximum of 10 samples at 20 to 30 min intervals.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Median Performance Error (MDPE)
Tidsramme: Up to 5 hours during the maintenance phase of anaesthesia, to allow a maximum of 10 samples at 20 to 30 min intervals.
The median value of ratio between the measured and predicted concentration of propofol to the predicted concentration (Performance error) in blood. Expressed as a percentage. This is a measure of overall bias of the target controlled infusion.
Up to 5 hours during the maintenance phase of anaesthesia, to allow a maximum of 10 samples at 20 to 30 min intervals.
Median Absolute Performance Error (MDAPE)
Tidsramme: Up to 5 hours during the maintenance phase of anaesthesia
The median value of the ratio of the absolute difference (excluding the sign) between the measured and predicted concentrations to the predicted concentration (Absolute performance error) in blood. Expressed as percentage. This is a measure of the accuracy of the target controlled infusion.
Up to 5 hours during the maintenance phase of anaesthesia
Wobble
Tidsramme: Up to 5 hours during the maintenance phase of anaesthesia
The median value of the difference between the individual performance errors and the Median Performance Error (MDPE). This is a measure of the distribution of the performance errors around the median.
Up to 5 hours during the maintenance phase of anaesthesia
Divergence
Tidsramme: Up to 5 hours during the maintenance phase of anaesthesia
The median of the regression coefficient of the performance error against time. This is a measure of how the target controlled infusion performs with time.
Up to 5 hours during the maintenance phase of anaesthesia

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Michael RJ Sury, FRCA PhD, Great Ormond Street Hospital For Children NHS Foundation Trust
  • Hovedetterforsker: Selvakumar Panchatsharam, MBBS FRCA, Great Ormond Street Hospital For Children NHS Foundation Trust

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2013

Primær fullføring (Faktiske)

1. juli 2013

Studiet fullført (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først innsendt

13. august 2013

Først innsendt som oppfylte QC-kriteriene

29. august 2013

Først lagt ut (Anslag)

30. august 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. august 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. august 2013

Sist bekreftet

1. august 2013

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Pelorus 1500

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