- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03076099
Dexmedetomidine on Post-operative Blood Pressure in Bain Arteriovenous Malformation Embolization
2017년 3월 6일 업데이트: Nan Jiang
Effects of Dexmedetomidine on Post-operative Blood Pressure in Patients Undergoing Brain Arteriovenous Malformation Embolization
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization.
The patients were randomized allocated to either Dexmedetomidine group or Control group.
Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline.
Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score, Ramsay score, and adverse events were recorded.
연구 개요
상세 설명
Aim of this trial is to study the effect of Dexmedetomidine on post-operative blood pressure in patients undergoing brain arteriovenous malformation embolization.
The patients were randomized allocated to either Dexmedetomidine group or Control group according to a random number.
Patients in Dexmedetomidine group will receive intravenous Dexmedetomidine while the control group will receive normal saline.
Post-operative anti-hypertensive drug, Visual analogue score,post-operative analgesics consumption, Quality of Recovery score-15 items, Ramsay score, and adverse events were recorded.
연구 유형
중재적
등록 (예상)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Guangdong
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Guangzhou, Guangdong, 중국, 510080
- 모병
- the First Affiliated Hospital of Sun Yetsen University
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연락하다:
- Yi Liu, Master
- 전화번호: +86 13632391455
- 이메일: liuyisysu@126.com
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연락하다:
- Nan Jiang, professor
- 전화번호: +86 20 28823350
- 이메일: NJiang_sysu@126.com
-
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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
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- patients undergoing brain arteriovenous malformation embolization in the fist affiliated hospital, Sun Yat-sen University, aged 18-65 years, available to chat with,and the tracheal tube was extubated after surgery immediately.
Exclusion Criteria:
- abuse anesthetic analgesics and sedative drugs, or allergic to Dexmedetomidine or other anesthetics, hypotension or bradycardia before surgery, severe pulmonary disease with saturation of pulse oximetry less than 90% before surgery, or patients refused to attend in this study.
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 |
|---|---|
|
실험적: Dexmedetomidine
Dexmedetomidine was administered intravenously when tracheal extubation, 1.2μg/kg Dexmedetomidine was mixed with 100 ml normal saline and maintained 4 hours constantly.
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1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
다른 이름들:
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위약 비교기: Control group
Normal Saline was administered intravenously when tracheal extubation,equal volume of normal saline was mixed with 100 ml normal saline and maintained 4 hours constantly.
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equal volume of normal saline was administered intravenously constantly after tracheal extubation.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
urapidil consumption
기간: the end of the 6th hour after tracheal extubation
|
urapidil consumption was recorded by nurses every hour
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the end of the 6th hour after tracheal extubation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
urapidil consumption on POD1
기간: the total consumption of urapidil on post-operative day 1.
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urapidil consumption was recorded by nurses every hour
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the total consumption of urapidil on post-operative day 1.
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urapidil consumption on POD2
기간: the total consumption of urapidil on post-operative day 2.
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urapidil consumption was recorded by nurses every hour
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the total consumption of urapidil on post-operative day 2.
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Visual Analogue score
기간: the end of the 6th hour after tracheal extubation
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visual analogue score was measured by visual analogue scale
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the end of the 6th hour after tracheal extubation
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Visual Analogue score at 24th hour
기간: the end of the 24th hour after tracheal extubation
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visual analogue score was measured by visual analogue scale
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the end of the 24th hour after tracheal extubation
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Visual Analogue score at 48th hour
기간: the end of the 48th hour after tracheal extubation
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visual analogue score was measured by visual analogue scale
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the end of the 48th hour after tracheal extubation
|
|
Quality of Recovery Score
기간: the end of the 6th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
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the end of the 6th hour after tracheal extubation
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Quality of Recovery Score at 24th hour
기간: the end of the 24th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 24th hour after tracheal extubation
|
|
Quality of Recovery Score at 48th hour
기간: the end of the 48th hour after tracheal extubation
|
Quality of Recovery Score was measured by a 15-item quality of recovery scale
|
the end of the 48th hour after tracheal extubation
|
|
Analgesics consumption
기간: the end of the 6th hour after tracheal extubation
|
Analgesics consumption was recorded by nurse every hour
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the end of the 6th hour after tracheal extubation
|
|
Analgesics consumption on POD1
기간: the total consumption of urapidil on post-operative day 1.
|
Analgesics consumption was recorded by nurse every hour
|
the total consumption of urapidil on post-operative day 1.
|
|
Analgesics consumption on POD2
기간: the total consumption of urapidil on post-operative day 2.
|
Analgesics consumption was recorded by nurse every hour
|
the total consumption of urapidil on post-operative day 2.
|
|
Bradycardia
기간: the end of the 6th hour after tracheal extubation
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a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
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the end of the 6th hour after tracheal extubation
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Bradycardia at 24th hour
기간: the end of the 24th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
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the end of the 24th hour after tracheal extubation
|
|
Bradycardia at 48th hour
기간: the end of the 48th hour after tracheal extubation
|
a heart rate of lower than 50 beats per minute was identified as bradycardia, frequency of bradycardia was recorded by nurse
|
the end of the 48th hour after tracheal extubation
|
|
PONV
기간: the end of the 6th hour after tracheal extubation
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post-operative nausea and vomiting (PONV) was recorded by nurse
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the end of the 6th hour after tracheal extubation
|
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PONV at 24th hour
기간: the end of the 24th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 24th hour after tracheal extubation
|
|
PONV at 48th hour
기간: the end of the 48th hour after tracheal extubation
|
post-operative nausea and vomiting (PONV) was recorded by nurse
|
the end of the 48th hour after tracheal extubation
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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)
2016년 1월 1일
기본 완료 (예상)
2017년 12월 31일
연구 완료 (예상)
2017년 12월 31일
연구 등록 날짜
최초 제출
2017년 3월 6일
QC 기준을 충족하는 최초 제출
2017년 3월 6일
처음 게시됨 (실제)
2017년 3월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 3월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 3월 6일
마지막으로 확인됨
2017년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NJiang2016-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
the IPD will not be shared with others, since following investigations based on this trial is about to start.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .