2022-501500-10-00招募中4 期
Impact of opioids on heart rate during rapid sequence intubation : Double-blind randomized controlled study (CANDY-CRASH).
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
Assess the impact of opioids on heart rate due to laryngoscopy at the time of intubation in rapid sequence.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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 occlusive syndrome (with or without naso-gastric tube), or failure to respect food <6 hours and/or water <2 hours
- •Patient regardless of body mass index (BMI)
- •Patient regardless of their orotracheal intubation criteria present during the anesthesia consultation
- •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 participating in another interventional clinical research
- •Patient under AME (State Medical Aid)
- •Patient on beta blockers
- •Atrial fibrillation or other rhythm or conduction disturbances
- •Patient in hemodynamic failure SBP < 90 mmHg and DBP < 60 mmHg) 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
结局指标
主要结局
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).
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
- 1a- Cormack score in each group
- 1b- Laryngoscopy of Macintosh® number for each group
- 1c- Use of a long bent mandrel for each group
- 2a- Percentage of patients with intraoperative vomiting at T2 for each group
- 2b- Percentage of patients requiring vasopressor before T2
- 2c- Percentage of patients with thoracic rigidity and/or bradycardia cardiac output < 50 beats per minute (bpm) at T2 for each group
- 3a- Absolute and relative variations of +-20% in SAP/DAP and MAP between T0 and T2
- 3b- Absolute and relative variations of +/- 20% in SAP/DAand MAP between T0 and T13
- 3c- Relative variation of +/- 20% of HR between T0 and T2
- 3d- Absolute and relative variations of +/- 20% of HR between T0 and T13.
研究者
Dr Marine FONTAINE
Scientific
Centre Hospitalier Sud Francilien
研究点 (1)
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