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

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ClinicalTrials.gov Identifier: NCT04073758
Recruitment Status : Enrolling by invitation
First Posted : August 29, 2019
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Jung Min Koo, Seoul St. Mary's Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chest Wall Disorder Drug: Dexmedetomidine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparing Analgesic Requirements in Patients Receiving Nuss Operation Using Remifentanil or Dexmedetomidine as Anesthetic Adjuvants
Actual Study Start Date : September 2, 2019
Estimated Primary Completion Date : February 21, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Dexmedetomidine
Comparing effects of remifentanil versus dexmedetomidine
Other Name: Remifentanil

Active Comparator: 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.
Drug: Dexmedetomidine
Comparing effects of remifentanil versus dexmedetomidine
Other Name: Remifentanil




Primary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 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.

  2. Visual Analogue Scale [ Time Frame: 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.

  3. Visual Analogue Scale [ Time Frame: 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.

  4. Visual Analogue Scale [ Time Frame: 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.


Secondary Outcome Measures :
  1. Amount of postoperative intravenous patient controlled analgesics (PCA) used [ Time Frame: At 60 minutes after the end of surgery ]
  2. Amount of fentanyl used postoperatively at the recovery unit [ Time Frame: At 60 minutes after the end of surgery ]
    Amount in micgrograms per wegith in kilograms (migrogram/kilogram)

  3. Time needed for postoperative rescue opioid analgesics [ Time Frame: At 60 minutes after the end of surgery ]
  4. Amount of remifentanil or dexmedetomidine used intraoperatively [ Time Frame: Immediately at the end of the surgery ]
  5. Intraoperative hemodynamic change: Systolic blood pressure [ Time Frame: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room ]
  6. Intraoperative hemodynamic change: Diastolic blood pressure [ Time Frame: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room ]
  7. Intraoperative hemodynamic change: mean blood pressure [ Time Frame: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room ]
  8. Intraoperative hemodynamic change: heart rate [ Time Frame: 30 minutes after the induction of anesthesia ]
  9. Intraoperative hemodynamic change: mean blood pressure [ Time Frame: At the end of the surgery, average of 90minutes after the induction of anesthesia ]
  10. Intraoperative hemodynamic change: heart rate [ Time Frame: At the end of the surgery, average of 90minutes after the induction of anesthesia ]
  11. Intraoperative hemodynamic change: Systolic blood pressure [ Time Frame: At the end of the surgery, average of 90minutes after the induction of anesthesia ]
  12. Intraoperative hemodynamic change: Diastolic blood pressure [ Time Frame: At the end of the surgery, average of 90minutes after the induction of anesthesia ]
  13. Rescue drugs (inotropics or vasopressors) used in order to correct hypotension or bradycardia [ Time Frame: Intraoperatively ]
  14. Postoperative complications [ Time Frame: 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)

  15. Postoperative complications [ Time Frame: 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)

  16. Postoperative complications [ Time Frame: 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)



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073758


Locations
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Korea, Republic of
Jung Min Koo
Seoul, Korea, Republic of
Sponsors and Collaborators
Jung Min Koo
Investigators
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Principal Investigator: Jung Min Koo, M.D Data recruitment
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Responsible Party: Jung Min Koo, Principal Investigator, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT04073758    
Other Study ID Numbers: KC19MCSI0334
First Posted: August 29, 2019    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jung Min Koo, Seoul St. Mary's Hospital:
Pectus Excavatum
Additional relevant MeSH terms:
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Dexmedetomidine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics