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Comparison of Analgesic Requirements in Patients Receiving Nuss Operation Using 2 Different Anesthetic Adjuvants (ARNRD)

18. mars 2020 oppdatert av: Jung Min Koo

Comparing Analgesic Requirements in Patients Receiving Nuss Operation Using Remifentanil or Dexmedetomidine as Anesthetic Adjuvants

Nowadays, general anaesthesia is carried under "balanced anesthesia technique" in which many anesthetic adjuvants are used simultaneously, including opioid analgesics in order to reduce the amount of inhalation agents. The most popular adjuvants used are remifentanil, which is an opioid analgesic, and dexmedetomidine. Both of these agents are short acting, can be infused with targeted concentrations, excreted shortly from the body with stable hemodynamics.

Remifentanil, when infused for more than 2 hours, causes hyperalgesia to increase the amount of pain postoperatively as well as the amount of opioid analgesics. However, dexmedetomidine does not cause hyperalgesia and is known to have an opioid -sparing effect. In our center.

In this study, we aim to compare the effects of remifentanil and dexmedetomidine on postoperative pain in patients undergoing Nuss procedure, which is a very painful operation on the chest wall.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

62

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

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

20 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Adults aged >20
  2. Patients undergoing Nuss bar operation (pectus excavatum repair surgery)
  3. American Society of Anesthesiologists classification I ~ III

Exclusion Criteria:

  1. Drug abuse history
  2. Chronic pain in need of continuous opioid analgesics administration
  3. History of psychiatric diseases
  4. Preoperative bradycardia (heart rate < 50/min) or arrythmia
  5. Cardiac diseases other than diabetes or hypertension - coronary artery disease, ischemic heart disease
  6. Moderate liver or kidney dysfunction
  7. Pregnant or breast feeding women
  8. Hypersensitivity to the study drugs
  9. Patients who do not agree to participate

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-komparator: Remifentanil group
In both interventional groups, Sevoflurane is used as an inhalational agent, in 0.5-1.5% age-adjusted Minimal Alveolar Concentration (MAC). As explained above, remifentanil is infused with Target Controlled Infusion pump, and concentration is adjusted so that Bispectral index (BIS) is maintained as 40-60, which means that the patients are maintained in general anesthesia. Remifentanil is usually infused with the effect site concentration of 2.0 to 6.0 ng/ml during general anesthesia. If bradycardia or hypotension develops due to remifentanil infusion, the infusion rate could be reduced, or inotropic, vasopressor, anticholinergic agents can be used (ephedrine, atropine, etc.) to correct the side effects of the drug, or the drug infusion can even be ceased. At the end of the surgery when skin closure starts, remifentanil infusion will be stopped.
Legemiddel: Dexmedetomidine
Comparing effects of remifentanil versus dexmedetomidine
Andre navn:
  • Remifentanil
Aktiv komparator: Dexmedetomidine group
In both interventional groups, Sevoflurane is used as an inhalational agent, in 0.5-1.5% age-adjusted MAC (Minimal Alveolar Concentration). As explained above, dexmedetomidine is infused with syringe pump, and concentration is adjusted so that Bispectral index (BIS) is maintained as 40-60, which means that the patients are maintained in general anesthesia. Dexmedetomidine is loaded for 10 minutes in 1mcg/kg, and then infusion rate is set between 0.4 to 0.6mcg/kg/hour for this study. If bradycardia or hypotension develops due to remifentanil infusion, the infusion rate could be reduced, or inotropic, vasopressor, anticholinergic agents can be used (ephedrine, atropine, etc.) to correct the side effects of the drug, or the drug infusion can even be ceased. At the end of the surgery when skin closure starts, dexmedetomidine infusion will be stopped.
Legemiddel: Dexmedetomidine
Comparing effects of remifentanil versus dexmedetomidine
Andre navn:
  • Remifentanil

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Visual Analogue Scale
Tidsramme: Between 1~6 hours postoperatively.
Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
Between 1~6 hours postoperatively.
Visual Analogue Scale
Tidsramme: Between 6~12 hours postoperatively.
Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
Between 6~12 hours postoperatively.
Visual Analogue Scale
Tidsramme: Between 12~24 hours postoperatively.
Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
Between 12~24 hours postoperatively.
Visual Analogue Scale
Tidsramme: Between 24~48 hours postoperatively.
Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
Between 24~48 hours postoperatively.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Amount of postoperative intravenous patient controlled analgesics (PCA) used
Tidsramme: At 60 minutes after the end of surgery
At 60 minutes after the end of surgery
Amount of fentanyl used postoperatively at the recovery unit
Tidsramme: At 60 minutes after the end of surgery
Amount in micgrograms per wegith in kilograms (migrogram/kilogram)
At 60 minutes after the end of surgery
Time needed for postoperative rescue opioid analgesics
Tidsramme: At 60 minutes after the end of surgery
At 60 minutes after the end of surgery
Amount of remifentanil or dexmedetomidine used intraoperatively
Tidsramme: Immediately at the end of the surgery
Immediately at the end of the surgery
Intraoperative hemodynamic change: Systolic blood pressure
Tidsramme: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
Intraoperative hemodynamic change: Diastolic blood pressure
Tidsramme: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
Intraoperative hemodynamic change: mean blood pressure
Tidsramme: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
Intraoperative hemodynamic change: heart rate
Tidsramme: 30 minutes after the induction of anesthesia
30 minutes after the induction of anesthesia
Intraoperative hemodynamic change: mean blood pressure
Tidsramme: At the end of the surgery, average of 90minutes after the induction of anesthesia
At the end of the surgery, average of 90minutes after the induction of anesthesia
Intraoperative hemodynamic change: heart rate
Tidsramme: At the end of the surgery, average of 90minutes after the induction of anesthesia
At the end of the surgery, average of 90minutes after the induction of anesthesia
Intraoperative hemodynamic change: Systolic blood pressure
Tidsramme: At the end of the surgery, average of 90minutes after the induction of anesthesia
At the end of the surgery, average of 90minutes after the induction of anesthesia
Intraoperative hemodynamic change: Diastolic blood pressure
Tidsramme: At the end of the surgery, average of 90minutes after the induction of anesthesia
At the end of the surgery, average of 90minutes after the induction of anesthesia
Rescue drugs (inotropics or vasopressors) used in order to correct hypotension or bradycardia
Tidsramme: Intraoperatively
Intraoperatively
Postoperative complications
Tidsramme: Between 1~6 hours postoperatively
Number of events that happened to the patient: e.g. Yes or No, and how many times. Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)
Between 1~6 hours postoperatively
Postoperative complications
Tidsramme: Between 12~24 hours postoperatively
Number of events that happened to the patient: e.g. Yes or No, and how many times. Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)
Between 12~24 hours postoperatively
Postoperative complications
Tidsramme: Between 24~48 hours postoperatively
Number of events that happened to the patient: e.g. Yes or No, and how many times. Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)
Between 24~48 hours postoperatively

Samarbeidspartnere og etterforskere

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

Sponsor

Jung Min Koo

Etterforskere

  • Hovedetterforsker: Jung Min Koo, M.D, Data recruitment

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 (Faktiske)

2. september 2019

Primær fullføring (Forventet)

21. februar 2021

Studiet fullført (Forventet)

28. februar 2021

Datoer for studieregistrering

Først innsendt

20. august 2019

Først innsendt som oppfylte QC-kriteriene

27. august 2019

Først lagt ut (Faktiske)

29. august 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. mars 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KC19MCSI0334

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

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produkt produsert i og eksportert fra USA

Nei

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