Impact of Opioids on Heart Rate During Rapid Sequence Intubation: Double-blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- heart rate beats per minute
研究概览
简要总结
The patient is seen upstream by an anaesthetists resuscitator (MAR) in order to carry out his anesthesia consultation. If the patient meets the eligibility criteria he will be informed of the study and his signed consent will be obtained.
Patients will be divided into 3 parallel groups :
- Group A (placebo +remifentanil)
- Group B (sufentanil + placebo)
- Group C (placebo + placebo)
Constants are taken at T0. A non-invasive continuous monitoring (Clearsight ©) will be used to collect data: blood pressure, heart rate, cardiac output.
To ensure double-blinding the nurse who prepares the syringes is not part of the anesthesia team. He/she numbers them in syringe n°1 and n°2 to indicate the order of injection to the MAR.
The MAR injects the drugs according to the standardized study plan (see below):
- T1: the patient receives an intravenous bolus (IV) over 5 seconds of molecule n°1
- 3 minute delay
- Patient receives Etomidate 0.3 mg/kg IV over 10 seconds
- 5 second delay
- The patient receives an IV bolus over 30 seconds of molecule n°2
- 5 second delay
- The patient receives Succinylcholine or Rocuronium IV over 5 seconds
- T2: End of induction, oro-tracheal intubation (= T2)
The laryngoscopy is performed by an experienced MAR or nurse (IADE). The end of the intubation is defined by the fixation of the intubation tube (T3). Hemodynamic parameters are measured every minute for ten minutes after intubation (T4 to T13).
Maintenance of anesthesia is standardized with halogen gas (SEVOFLURANE) and an opioid (SUFENTANIL). Ten minutes after the patient's intubation (T13), the blind is lifted, allowing the addition of sufentanil in groups A and C before any surgical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 65 years old and any possible ASA OR Patient aged 55 to 65 years old with an ASA ≥ 3,
- •Patient undergoing surgery (urgent or scheduled), requiring general anesthesia in rapid sequence, because considered to have a "full stomach", i.e. with: gastro-oesophageal pathology or gastroparesis or a history of bariatric surgery or food intake within two hours for liquids and within six hours for solids,
- •Patient informed of the study who gave their written consent before starting the study procedures,
- •Patient affiliated to a French social security system.
排除标准
- •Patient < 55 years old,
- •Patient on beta blockers,
- •Atrial fibrillation or other rhythm or conduction disturbances,
- •Patient in hemodynamic failure and/or on catecholamines before the start of GA,
- •Patient having a history of stroke, hemorrhagic and/or ischemic and/or transient
- •Combination with opioid agonists-antagonists or partial opioid antagonists
- •Known hypersensitivity to one of the study drugs or to opioids,
- •History of difficult intubation,
- •Patient under guardianship, curatorship or deprived of liberty,
- •Patient participating in another interventional clinical research,
- •Patient under AME (State Medical Aid)
研究组 & 干预措施
Group B (sufentanil + placebo)
干预措施: Sufentanil (Drug)
Group B (sufentanil + placebo)
干预措施: Placebo (Drug)
Group A (placebo + remifentanil)
干预措施: Placebo (Drug)
Group C (placebo + placebo)
干预措施: Placebo (Drug)
Group A (placebo + remifentanil)
干预措施: Remifentanil (Drug)
结局指标
主要结局
heart rate beats per minute
时间窗: T2 : oro-tracheal induction
Absolute variation of heart rate beats per minute between T0 (reference value at the entrance into the operating room) and T2 (end of induction and oro-tracheal intubation)
次要结局
- Cormack score(T2 : oro-tracheal induction)
- Laryngoscopy of Macintosh number(T2 : oro-tracheal induction)
- Use of a long bent mandrel(T2 : oro-tracheal induction)
- assess side effects according to the opioids used(T2 : oro-tracheal induction)
- assess significant variation in hemodynamic responses(T13 (10 minutes after intubation))