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Concentrations of Remifentanil for Extubation (REMEX)

16. mars 2016 oppdatert av: LUIS ALBERTO TAFUR B, Seganest

Effect of Two Plasma Concentrations of Remifentanil Through Target Controlled Anesthesia on Frequency and Intensity of Coughing During Extubation: Randomized Controlled Clinical Trial

Condition of the State: (terminated, recruiting, etc.) Terminated

Study Design: Main Objective:

Compare the frequency and intensity of coughing at the time of extubation with two infusions of remifentanil that predict a plasma concentration (PC) of 3 - 4 and 2 - 3 ng/ml, through the technique of target controlled anesthesia

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Phase of the study:

Phase IV

Intervention:

Drug: U Extubation

Other Names:

Concentration 2 - 3 ng/ml Dose of remifentanil according to the randomization: Letter U between 2 - 3 ng/ml. The infusions that were used to reach the (PC) target were: Group U = 2 - 3 ng/ml. 20 years old - 6.0 mcg/Kg/h, 30 years old - 5.7 mcg/Kg/h, 40 years old - 5.3 mcg/kg/h, 50 years old - 5.0 mcg/kg/h, 60 years old - 4.6 mcg/kg/h, 70 years old - 4.3 mcg/kg/h, 80 years old - 4.0 mcg kg/h.

Drug: Extubation T

Other Names:

Concentration 3 - 4 ng/ml Dose of infusion of remifentanil to reach a (PC) 3 - 4 ng/ml, in the following manner: The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient. The remifentanil dose was adjusted according to the randomization: Group T = 3 - 4 ng/ml. 20 years old - 9.0 mcg/Kg/h, 30 years old - 8.5 mcg/Kg/h, 40 years old - 8.0 mcg/kg/h, 50 years old - 7.5 mcg/kg/h, 60 years old - 7.0 mcg/kg/h, 70 years old - 6.5 mcg/kg/h, 80 years old - 6.0 mcg kg/h.

Number of arms:

2

Masking:

The patient had masking with regards to the anesthetic procedure from the unfamiliarity per se of the same and by agents used in this that induced anxiolysis and hypnosis.

To guarantee the masking to the viewer, which was the treating anesthesiologist, a nurse was trained in the adjustment of the infusion balloon. Ten minutes before concluding the procedure and by request of the anesthesiologist, the nurse proceeded to locate balloon in such a way that the infusion could not be seen by the anesthesiologist, then opened the envelope and adjusted the infusion according to the randomization (U) o (T). The evaluation of the cough, its intensity and the Ramsay were under the care of the anesthesiologist, who was unaware of the awakening infusion.

Allocation:

Two were allocated for the use: Concentration of remifentanil of 2 - 3 ng/ml (group U) and concentration of remifentanil of 3 - 4 ng/ml (group T).

Recruitment:

A patient was recruited between the period of January 2011 and July 2012.

Studietype

Intervensjonell

Registrering (Faktiske)

110

Fase

  • Fase 4

Kontakter og plasseringer

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

Studiesteder

    • Valle del Cauca
      • Santiago de Cali, Valle del Cauca, Colombia, 288 00
        • Instituto Para Niños Ciegos y Sordos del Valle del Cauca

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

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • All patients aged 18-70 years
  • Risk Scale American Society of Anaesthesiologists physical status classification (ASA) I and II
  • Undergoing elective ear surgery

Exclusion Criteria:

  • Patients who are contraindicated remifentanil
  • Patients undergoing emergency surgery
  • Pulmonary Pathology (ASTHMA - COPD)
  • Index of body mass greater than 35
  • Background of respiratory failure three weeks prior to the procedure
  • Smokers

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Extubation U
Remifentanil concentration between 2 - 3 ng/ml.

Dose of remifentanil according to the randomization; the infusions that were used to reach the PC target were:

  • 20 years old - 6.0 mcg/Kg/h
  • 30 years old - 5.7 mcg/Kg/h
  • 40 years old - 5.3 mcg/kg/h
  • 50 years old - 5.0 mcg/kg/h
  • 60 years old - 4.6 mcg/kg/h
  • 70 years old - 4.3 mcg/kg/h
  • 80 years old - 4.0 mcg kg/h.
Andre navn:
  • Ultiva
Eksperimentell: Extubation T
Remifentanil concentration between 3 - 4 ng/ml

Dose of infusion of remifentanil to reach a PC 3 - 4 ng/ml, in the following manner:

The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient.

The remifentanil dose was adjusted according to the randomization:

  • 20 years old - 9.0 mcg/Kg/h
  • 30 years old - 8.5 mcg/Kg/h
  • 40 years old - 8.0 mcg/kg/h
  • 50 years old - 7.5 mcg/kg/h
  • 60 years old - 7.0 mcg/kg/h
  • 70 years old - 6.5 mcg/kg/h
  • 80 years old - 6.0 mcg kg/h.
Andre navn:
  • Ultiva

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Cough
Tidsramme: It is evaluated by the scale of cough over a two hour period after surgery: is assessed at 5 minutes turned off the halogenated inhalation anesthetics, thereafter every minute until the patient responds to verbal stimulus and can be extubated

Number of episodes and duration of cough that occur when the patient responds to verbal stimulus and extubated.

Cough Scale

  • Grade 0 = No cough
  • Grade 1 = Mild (only episode of cough)
  • Grade 2 = Moderate (more than 1episode of cough during less than 5 seconds)
  • Grade 3 = Severe (More than one episode of cough that lasted more than 5 seconds or purposeless movements of the extremities).
It is evaluated by the scale of cough over a two hour period after surgery: is assessed at 5 minutes turned off the halogenated inhalation anesthetics, thereafter every minute until the patient responds to verbal stimulus and can be extubated

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Wake time.
Tidsramme: During two hours after surgery, five minutes after turning off halogenated inhaled anesthetics, then every minute until the patient opens his eyes and is extubated.

When vaporizer where closed until the patient responds to the verbal stimulus and is extubated.

Defined as the time taken to open eyes after having turned off the halogenated inhalation anesthetics.

During two hours after surgery, five minutes after turning off halogenated inhaled anesthetics, then every minute until the patient opens his eyes and is extubated.
Ramsay scale at the time of extubation
Tidsramme: During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered

Ramsay scale: score objective system for measuring drug-induced sedation

  • Score 1: Anxious or restless or both
  • Score 2: Cooperative, orientated and tranquil
  • Score 3: Responding to commands
  • Score 4: Brisk response to stimulus
  • Score 5: Sluggish response to stimulus
  • Score 6: No response to stimulus
During two hours after surgery, the estimated time period during which the event was assessed five (5) minutes after every minute, until answered

Samarbeidspartnere og etterforskere

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

Sponsor

Etterforskere

  • Hovedetterforsker: LUIS A TAFUR, MD, Seganest
  • Studieleder: Eduardo Lema, MD, Seganest

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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 2011

Primær fullføring (Faktiske)

1. januar 2011

Studiet fullført (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først innsendt

27. august 2013

Først innsendt som oppfylte QC-kriteriene

16. mars 2016

Først lagt ut (Anslag)

17. mars 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. mars 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mars 2016

Sist bekreftet

1. mars 2016

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

IPD-planbeskrivelse

The individual data of the participants (IPD) were only available to the ethics committee of the institution.

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. .

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