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

18. marts 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

20 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Medicin: Dexmedetomidine
Comparing effects of remifentanil versus dexmedetomidine
Andre navne:
  • 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.
Medicin: Dexmedetomidine
Comparing effects of remifentanil versus dexmedetomidine
Andre navne:
  • Remifentanil

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Jung Min Koo

Efterforskere

  • Ledende efterforsker: Jung Min Koo, M.D, Data recruitment

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 (Faktiske)

2. september 2019

Primær færdiggørelse (Forventet)

21. februar 2021

Studieafslutning (Forventet)

28. februar 2021

Datoer for studieregistrering

Først indsendt

20. august 2019

Først indsendt, der opfyldte QC-kriterier

27. august 2019

Først opslået (Faktiske)

29. august 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. marts 2020

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KC19MCSI0334

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