- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02016391
Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours
Effects of Dexmedetomidine on Periprocedural Pain During Radiofrequency Ablation of Liver and Kidney Tumours
연구 개요
상세 설명
Although radiofrequency ablation (RF) is accepted as the best therapeutic choice for patients with early stage hepatocellular carcinoma when liver transplantation or surgical resection are not suitable options, it is still performed only in a few hospitals and experience is so far limited (Goldberg & Ahmed, 2002; Shiina et al., 2005). In addition, RF ablation is emerging as a viable alternative to surgery for inoperable patients with limited hepatic metastatic disease, especially from colorectal cancer. Although radiofrequency ablation has been accepted as a safe and effective treatment for liver and kidney tumours, there are few studies addressing periprocedural pain.
Thus, the optimal anaesthetic procedure is still to be determined. Currently at our institution RF is performed as monitored sedation procedure using remifentanil infusion supplemented with midazolam boluses, when considered necessary. However, when using remifentanil and midazolam combination it is quite difficult to avoid too deep respiratory depression.
Dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic effects, and it has more selective α2-adrenergic effect than clonidine. Dexmedetomidine has a great deal of potential in this arena given its analgesic and anxiolytic properties while preserving respiratory drive (Bergese SD et al., 2010).
All patients will receive dexmedetomidine 0.4 µg/kg/hr infusion from the start of procedure. The infusion will be continued during the whole RF procedure.
At the same time all patients will receive remifentanil infusion according to TCI (target controlled infusion) protocol. Plasma concentration target will be set from 0.5 ng/ml and, if necessary, will be increased to achieve a comfortable state of patient (Ramsey Sedation Scale: 2-3).
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Uppsala, 스웨덴, 75185
- Uppsala University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- liver or/and kidney cancer for which radiofrequency ablation procedure is planned
- signed informed consent form
Exclusion Criteria:
- patient refusal
- pregnancy
- known allergy to dexmedetomidine or remifentanil
- atrioventricular block grade II or III or other significant cardiac conduction disturbance
- stroke
- low blood pressure not responding to treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 덱스메데토미딘
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Dexmedetomidine 0.4 µg/kg/hr infusion during RF procedure
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Satisfaction With Sedation Technique
기간: After completion of procedure (within 15 minutes)
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Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied
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After completion of procedure (within 15 minutes)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vital signs: blood pressure, oxygen saturation, heart rate, breathing rate
기간: During procedure and up to 2 hours stay at the post-anesthesia care unit
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During procedure and up to 2 hours stay at the post-anesthesia care unit
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Ramsey Sedation Scale Score
기간: During the procedure and up to 2 hours stay at the post-anesthesia care unit
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Rating of depth of sedation.
Scale 1 - 6, 1 being wide awake and 6 being non-responsive
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During the procedure and up to 2 hours stay at the post-anesthesia care unit
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Maximal pain intensity
기간: During procedure and up to 2 hours stay at the post-anesthesia care unit
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The 11-point Numerical Rating Scale (NRS) to assess periprocedural pain.
Scale of 0-10, with 0:no pain and 10: pain as bad as it could be
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During procedure and up to 2 hours stay at the post-anesthesia care unit
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공동 작업자 및 조사자
수사관
- 수석 연구원: Egidijus Semenas, MD, PhD, Uppsala University Hospital, Uppsala, Sweden
- 수석 연구원: Mats Eriksson, MD, PhD, Uppsala University Hospital, Uppsala, Sweden
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RF-01
- 2013/409 (Uppsala Regional Ethics Committee)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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