Phase 3 Therapeutic Interventional Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery - Single-centre Prospective Randomised Controlled Study With Blinded Assessment of the Primary Endpoint
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Intubation-related hypotension
研究概览
简要总结
Arterial hypotension during general anaesthesia (GA) is a serious event. While hypotension can occur during surgery, it usually occurs following induction of GA (i.e. following the injection of drugs to enable intubation). This is due to the injection of large doses of anaesthetic drugs with a vasodilatory effect over a short period of time to induce a deep sleep to allow intubation to take place for artificial ventilation.
The prevention of hypotension during surgery has been extensively studied. In contrast, the prevention of hypotension following GA induction has been the subject of only two randomised studies in the ICU and three non-randomised studies in the OR with small numbers of patients. The level of evidence for the use of noradrenaline in the operating theatre remains low.
The hypothesis of the study is that noradrenaline initiated during preoxygenation can reduce the incidence of hypotension during induction of general anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patient under anesthesia will not be aware of randomisation arm. the team collecting primary endpoint (hypotension under 55 mg during the 20 minutes after the start of anesthesia) will not be aware of patient assignation.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requiring cardiac or thoracic surgery under general anaesthesia
- •Requiring a blood pressure catheter prior to GA induction
排除标准
- •Hemodynamic instability on arrival in the operating room
- •Hypotension on arrival in the operating theatre: Systolic blood pressure < 100 mmHg or Mean arterial pressure < 65 mmHg
- •Hypertension on arrival at the operating theatre: Systolic blood pressure > 160 mmHg or Mean arterial pressure > 100 mmHg
- •Adult under guardianship, curatorship or safeguard of justice
- •Unable to give consent
- •Pregnant or breastfeeding woman
- •Emergency surgery (cannot be delayed by 24 hours)
- •Current participation in an interventional protocol that interferes with the evaluation criteria of the study
- •Not affiliated to or not benefiting from a social security scheme
- •Lack of informed and written consent from the patient
- •Patient with a dilated aorta with a risk of rupture (e.g. chronic dissection for example)
- •Patient with severe aortic insufficiency
- •Treated hypertensive history that may have hypersensitivity to noradrenaline and hypertensive flares hypertensive attacks
研究组 & 干预措施
Noradrenaline
Noradrenaline diluted to 16µg/ml infused at 0.06g/kg/min by peripheral venous line from the start of peripheral venous line from the start of preoxygenation
干预措施: noradrenaline (Drug)
结局指标
主要结局
Intubation-related hypotension
时间窗: Within 20 minutes of the start of general anesthesia (induction)
Occurrence of at least one episode of arterial hypotension defined by a Mean Arterial Pressure below 55 mmHg with Mean Blood Pressure = (Systolic Blood pressure + 2xDiastolic Blood Pressure)/3
次要结局
- Occurrence of complications(Within 20 minutes of the start of the intubation)
- ECC Cardiac Output(Within 20 minutes of the start of the intubation)
- Duration of episodes of hypotension(Within 20 minutes of the start of the intubation)
- ECC Mean Arterial Pressure(Within 20 minutes of the start of the intubation)
- Total dose of vasopressor(Within 20 minutes of the start of the intubation)
- ECC Arterial Line Temperature(Within 20 minutes of the start of the intubation)
- ECC duration(Within 20 minutes of the start of the intubation)
- Hypotension event(Within 20 minutes of the start of the intubation)
- Hypertension event(Within 20 minutes of the start of the intubation)
- ECC SaO2(Within 20 minutes of the start of the intubation)
- ECC SvO2(Within 20 minutes of the start of the intubation)
- ECC PaCO2(Within 20 minutes of the start of the intubation)
- ECC Arterial Line Pressure(Within 20 minutes of the start of the intubation)
- ECC VO2(Within 20 minutes of the start of the intubation)
- ECC PaO2(Within 20 minutes of the start of the intubation)
- Delirium score(After extubation within 48 hours postoperatively)
- Postoperative invasive ventilation duration(Until 28 days after surgery)
- Duration of Noradrenaline and Dobutamine treatments(Within 28 days after surgery)
- PaO2/FiO2(In the 5 post-operative days)
- Dialysis(Within 28 days after surgery)
- Hemolysis index(In the 5 post-operative days)
- Acute renal failure(In the 5 post-operative days)
- CVA(In the 5 post-operative days)
- Mortality(Until 28 days after surgery)
- Stay in intensive care duration(Until 28 days after surgery)
- Hospitalization duration(Until 28 days after surgery)