- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04073758
Comparison of Analgesic Requirements in Patients Receiving Nuss Operation Using 2 Different Anesthetic Adjuvants (ARNRD)
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.
Přehled studie
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Seoul, Korejská republika
- Jung Min Koo
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Adults aged >20
- Patients undergoing Nuss bar operation (pectus excavatum repair surgery)
- American Society of Anesthesiologists classification I ~ III
Exclusion Criteria:
- Drug abuse history
- Chronic pain in need of continuous opioid analgesics administration
- History of psychiatric diseases
- Preoperative bradycardia (heart rate < 50/min) or arrythmia
- Cardiac diseases other than diabetes or hypertension - coronary artery disease, ischemic heart disease
- Moderate liver or kidney dysfunction
- Pregnant or breast feeding women
- Hypersensitivity to the study drugs
- Patients who do not agree to participate
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Falešný srovnávač: 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.
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Comparing effects of remifentanil versus dexmedetomidine
Ostatní jména:
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Aktivní komparátor: 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.
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Comparing effects of remifentanil versus dexmedetomidine
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Visual Analogue Scale
Časové okno: Between 1~6 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 1~6 hours postoperatively.
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Visual Analogue Scale
Časové okno: Between 6~12 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 6~12 hours postoperatively.
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Visual Analogue Scale
Časové okno: Between 12~24 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 12~24 hours postoperatively.
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Visual Analogue Scale
Časové okno: Between 24~48 hours postoperatively.
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Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.
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Between 24~48 hours postoperatively.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Amount of postoperative intravenous patient controlled analgesics (PCA) used
Časové okno: At 60 minutes after the end of surgery
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At 60 minutes after the end of surgery
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Amount of fentanyl used postoperatively at the recovery unit
Časové okno: At 60 minutes after the end of surgery
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Amount in micgrograms per wegith in kilograms (migrogram/kilogram)
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At 60 minutes after the end of surgery
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Time needed for postoperative rescue opioid analgesics
Časové okno: At 60 minutes after the end of surgery
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At 60 minutes after the end of surgery
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Amount of remifentanil or dexmedetomidine used intraoperatively
Časové okno: Immediately at the end of the surgery
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Immediately at the end of the surgery
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Intraoperative hemodynamic change: Systolic blood pressure
Časové okno: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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Intraoperative hemodynamic change: Diastolic blood pressure
Časové okno: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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Intraoperative hemodynamic change: mean blood pressure
Časové okno: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
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Intraoperative hemodynamic change: heart rate
Časové okno: 30 minutes after the induction of anesthesia
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30 minutes after the induction of anesthesia
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Intraoperative hemodynamic change: mean blood pressure
Časové okno: At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Intraoperative hemodynamic change: heart rate
Časové okno: At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Intraoperative hemodynamic change: Systolic blood pressure
Časové okno: At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Intraoperative hemodynamic change: Diastolic blood pressure
Časové okno: At the end of the surgery, average of 90minutes after the induction of anesthesia
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At the end of the surgery, average of 90minutes after the induction of anesthesia
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Rescue drugs (inotropics or vasopressors) used in order to correct hypotension or bradycardia
Časové okno: Intraoperatively
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Intraoperatively
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Postoperative complications
Časové okno: Between 1~6 hours postoperatively
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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)
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Between 1~6 hours postoperatively
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Postoperative complications
Časové okno: Between 12~24 hours postoperatively
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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)
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Between 12~24 hours postoperatively
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Postoperative complications
Časové okno: Between 24~48 hours postoperatively
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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)
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Between 24~48 hours postoperatively
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jung Min Koo, M.D, Data recruitment
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Fyziologické účinky léků
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Depresiva centrálního nervového systému
- Agenti periferního nervového systému
- Analgetika
- Agenti smyslového systému
- Analgetika, nenarkotika
- Agonisté adrenergních alfa-2 receptorů
- Adrenergní alfa-agonisté
- Adrenergní agonisté
- Analgetika, opiáty
- Narkotika
- Hypnotika a sedativa
- Remifentanil
- Dexmedetomidin
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