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

18 mars 2020 uppdaterad 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Förväntat)

62

Fas

  • Inte tillämpbar

Kontakter och platser

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Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 60 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Sham Comparator: 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.
Läkemedel: Dexmedetomidine
Comparing effects of remifentanil versus dexmedetomidine
Andra namn:
  • 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.
Läkemedel: Dexmedetomidine
Comparing effects of remifentanil versus dexmedetomidine
Andra namn:
  • Remifentanil

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Visual Analogue Scale
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Amount of postoperative intravenous patient controlled analgesics (PCA) used
Tidsram: 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
Tidsram: 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
Tidsram: At 60 minutes after the end of surgery
At 60 minutes after the end of surgery
Amount of remifentanil or dexmedetomidine used intraoperatively
Tidsram: Immediately at the end of the surgery
Immediately at the end of the surgery
Intraoperative hemodynamic change: Systolic blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 30 minutes after the induction of anesthesia
30 minutes after the induction of anesthesia
Intraoperative hemodynamic change: mean blood pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Intraoperatively
Intraoperatively
Postoperative complications
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Jung Min Koo

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 september 2019

Primärt slutförande (Förväntat)

21 februari 2021

Avslutad studie (Förväntat)

28 februari 2021

Studieregistreringsdatum

Först inskickad

20 augusti 2019

Först inskickad som uppfyllde QC-kriterierna

27 augusti 2019

Första postat (Faktisk)

29 augusti 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 mars 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 mars 2020

Senast verifierad

1 mars 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KC19MCSI0334

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