Comparison of Analgesic Requirements in Patients Receiving Nuss Operation Using 2 Different Anesthetic Adjuvants (ARNRD)
2020년 3월 18일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (예상)
62
단계
- 해당 없음
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연구 장소
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Seoul, 대한민국
- Jung Min Koo
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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가짜 비교기: 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
다른 이름들:
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활성 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Visual Analogue Scale
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Amount of postoperative intravenous patient controlled analgesics (PCA) used
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Intraoperatively
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Intraoperatively
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Postoperative complications
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Jung Min Koo, M.D, Data recruitment
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 9월 2일
기본 완료 (예상)
2021년 2월 21일
연구 완료 (예상)
2021년 2월 28일
연구 등록 날짜
최초 제출
2019년 8월 20일
QC 기준을 충족하는 최초 제출
2019년 8월 27일
처음 게시됨 (실제)
2019년 8월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 3월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 3월 18일
마지막으로 확인됨
2020년 3월 1일
추가 정보
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키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- KC19MCSI0334
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