- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06564857
비디오 후두경 검사 보조 기관 삽관 최적화를 위한 Remifentanil과 Rocuronium 비교 (ROCVIDEO)
전신 마취를 받는 환자의 비디오 후두경 검사 보조 기관 삽관 최적화를 위한 Remifentanil 대 Rocuronium - 다기관 무작위 대조 시험 - ROCVIDEO 시험
Globally, we are approaching 1 million surgical procedures each day. Tracheal intubation is the mainstay of securing the patient's airway and breathing during general anaesthesia. Approximately 100.000 tracheal intubations are performed annually in Denmark. Airway management remains the primary reason for anaesthesia-related morbidity and mortality. It has been traditionally accepted that best tracheal intubation conditions are obtained by paralysing the patient's muscles, including vocal cords, using a neuromuscular blocking agent (NMBA) such as rocuronium. However, using NBMA may increase the risk of pulmonary complications, intra-operative awareness, in which the patient is paralysed but awake during surgery, anaphylaxis, and re-intubation. In addition, there is a risk of residual neuromuscular blockade postoperatively. In the US, prolonged ventilation and unplanned intubation are the top two most costly perioperative complications. An alternative to NMBA is a large dose of opioids to depress laryngeal reflexes during intubation. The most commonly used non-NMBA modality includes bolus administration of remifentanil. However, remifentanil may cause bradycardia and hypotension. Even short periods of hypotension have been shown to increase the risk of myocardial injury and other serious adverse events such as renal failure, delirium, and even mortality.
Evidence also indicates that intubation conditions using only opioids to facilitate intubation, including remifentanil, are inferior to NMBA. However, these trials are underpowered to assess effects on patient-important outcomes and are mostly at high risk of bias. A recent trial has suggested that remifentanil intubation conditions may not be very different. Almost all existing research comparing NMBA to opioids has focused on intubation conditions for direct laryngoscopy using a conventional Macintosh laryngoscopy blade. In recent years, the implementation and availability of the video laryngoscope have grown exponentially and become universal. The video laryngoscope has vastly improved the ease of tracheal intubation, and the number of failed intubations has decreased by two-thirds in Denmark, where a rapid implementation of the video laryngoscope took place. However, limited evidence exists on whether NMBA improves intubation conditions compared to remifentanil when performing video laryngoscope-assisted tracheal intubation.
연구 개요
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Anders K Nørskov, PhD
- 전화번호: +45 48292510
- 이메일: anders.kehlet.noerskov@regionh.dk
연구 연락처 백업
- 이름: Lars H Lundstrøm, PhD
- 전화번호: +45 48296512
- 이메일: lars.hyldborg.lundstroem.02@regionh.dk
연구 장소
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Copenhagen, 덴마크, 2100
- 모병
- Department of Anesthesiology, NOH, Rigshospitalet
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연락하다:
- Matias Vedsted, MD, PhD
- 전화번호: +4535457547
- 이메일: matias.vested@regionh.dk
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Hillerød, 덴마크, 3400
- 모병
- Department of Anesthesiology, North Zeeland Hospital
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연락하다:
- Lars Lundstrøm, MD, Phd
- 전화번호: +4548296512
- 이메일: lars.hyldborg.lundstroem.02@regionh.dk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults ≥ 18 years
- Undergoing general anaesthesia requiring oro-tracheal intubation
- Absence of indication for rapid sequence induction
- American Society of Anesthesiologists (ASA) physical status score I - III
Exclusion Criteria:
- Known allergies or contraindications to rocuronium (e.g. neuromuscular disease) or remifentanil
- Awake intubation
- Double-lumen endotracheal tube
- Oral, pharyngeal, and laryngeal surgery
- Surgical contraindication for NMBAs (e.g. use of nerve stimulator)
- Patients who are pregnant or breastfeeding
- Patients who do not understand Danish or are unable to give informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: REMI-arm
Bolus of remifentanil at anaesthesia induction |
Age < 70 years: Bolus of 4 μg/kg Ideal Body Weight remifentanil at anaesthesia induction; Age >= 70 years: Bolus of 2 μg/kg ideal Body Weight remifentanil at anaesthesia induction
다른 이름들:
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활성 비교기: ROCU-arm
Bolus of rocuronium at anaesthesia induction |
Bolus of 0.6 mg/kg Ideal Body Weight rocuronium at anaesthesia induction
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants with one or more intubation or anaesthesia related adverse events
기간: 0 minutes to 24 hours after administration of drugs for intubation
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Early (< 10 min): Cardiac arrest; anaphylaxis; pulmonary aspiration of gastric content; serious traumatic airway injury; desaturation (SAT < 90%); major hemodynamic instability (MAP < 50, new onset bradycardia < 40 beats/min); or sustained new arrhythmia (causing hemodynamic instability or requiring intervention). Late (< 24 h): Death; brain damage including stroke; acute myocardial infarction; ICU admission; re-intubation; respiratory failure (oxygen demand > 5 l/min or requiring interventions aside from oxygen therapy); intraoperative awareness; pneumonia; dental injury; sore throat; or hoarseness. |
0 minutes to 24 hours after administration of drugs for intubation
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Proportion of participants with failed first-pass intubation
기간: Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.
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Defined as failed tracheal tube delivery after the first attempt of introduction of the video laryngoscope into the patient's mouth. Tracheal tube delivery is defined as failed when the tube is retracted out of the patient's mouth, OR the video laryngoscope has to be retracted out of the patient's mouth, OR there is a shift in intubation equipment OR a change in the person performing the intubation management OR the intubation is abandoned. |
Tracheal intubation is performed 2 minutes after administration of rocuronium or remifentanil.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient satisfaction score
기간: 24 hours after administration of drugs for intubation
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The patient's experience of the treatment using a numeric rating scale (NRS 0 - 10 (0 = very dissatisfied; 10 = very satisfied)) |
24 hours after administration of drugs for intubation
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Proportion of participants with one or more serious adverse events 0-7 days
기간: 0 minutes to 7 days after administration of drugs for intubation
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Defined as: respiratory failure, major adverse cardiac (in-hospital all-cause death, acute myocardial infarction (AMI) both acute ST elevation MI and non-ST elevation MI, complete heart block, cardiogenic shock, cardiac arrhythmia and cardiac arrest), pneumonia, acute kidney injury, admission to ICU and cerebrovascular event (ischemic stroke including transient cerebral ischemia). |
0 minutes to 7 days after administration of drugs for intubation
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Lengths of stay at the Post-Anaesthesia Care Unit.
기간: 0-48 hours postoperatively
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Minutes the patient is at the Post-Anaesthesia Care Unit. |
0-48 hours postoperatively
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants with failed intubation
기간: 2 to 20 minutes after administration of drugs for intubation
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The intubation is abandoned |
2 to 20 minutes after administration of drugs for intubation
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Number of intubation attempts
기간: 2 to 20 minutes after administration of drugs for intubation
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The first attempt is defined as an attempt (successful or not) at tracheal tube delivery after the first introduction of the video laryngoscope into the patient's mouth. Additionally attempts are defined as: when the tube has to be re-introduced into the patient's mouth, OR the videolaryngoscopy has to be re-introduced into the patient mouth, OR there is a shift in intubation equipment OR a change in the person performing the intubation management |
2 to 20 minutes after administration of drugs for intubation
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Vocal cords position at first intubation attempt
기간: 2 to 20 minutes after administration of drugs for intubation
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Categorised as closed, intermediate or open |
2 to 20 minutes after administration of drugs for intubation
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Proportion of participants with need for rescue medication or airway management
기간: 2 to 20 minutes after administration of drugs for intubation
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Rescue medication is defined as: An additional bolus of neuromuscular blocking agents, or bolus of opioid or propofol or other anesthetics according to the discretion of the attending anaesthesiologist in order to solve insufficient airway management conditions. |
2 to 20 minutes after administration of drugs for intubation
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Proportion of participants with anaesthesia induction related grave desaturation
기간: 0 to 10 minutes after administration of drugs for intubation
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SAT < 80% |
0 to 10 minutes after administration of drugs for intubation
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Proportion of participants in need of vasoactive or chronotropic substances after induction
기간: 0 to 10 minutes after administration of drugs for intubation
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Defined as any vasoactive substance, e.g. epinephrine, noradrenaline, phenylephrine, ephedrine administrated as a response to severe hypotension or bradycardia after induction. |
0 to 10 minutes after administration of drugs for intubation
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Individual components of the composite outcomes "Proportion of participants with one or more intubation or anaesthesia related adverse events" and "Proportion of participants with one or more serious adverse events 0-7 days"
기간: 0 minutes to 7 days after administration of drugs for intubation
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As stated in the relevant outcome descriptions |
0 minutes to 7 days after administration of drugs for intubation
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Anders K Nørskov, PhD, Department of Anaesthesia, Nordsjællands Hospital - Hillerød, Denmark
- 수석 연구원: Matias Vested, PhD, Department of Anaesthesia Centre of Head and Orthopedics Rigshospitalet, University of Copenhagen
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ROCVIDEO
- 2025-521405-40-01 (씨티스)
- 2025 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Anonymised data will be made available upon reasonable request
IPD 공유 기간
The protocol is submitted prior to first randomisation. A comprehensive statistical analysis plan, including pre-specified subgroup analysis will be published before the final participant is enrolled.
Other material will be made available <12 months after trial cessation
IPD 공유 액세스 기준
Anonymised data will be made available upon reasonable request.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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