Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room

Официальное название

Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room: a 3-arm Randomized Trial

Обзор

The best hypnotic choice to optimize the balance between good intubation condition quality and hemodynamic stability during RSI performed in the operating theatre remained to be investigated. Therefore, a randomized study evaluating the efficacy of propofol, ketamine, and a combination of both is appropriate. So, we designed the HyPnotiKs randomized controlled study to investigate the efficacy of these hypnotic drugs in patients undergoing RSI in the operating theatre. The primary endpoint will be the successful tracheal intubation at the first attempt without major arterial hypotension event.

Вмешательства

• Препарат direct IV injection
  direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI \> 30) after completing pre-oxygenation
• Препарат combination of Ketamine and Propofol
  combination of Ketamine and Propofol described above: consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg (adjusted body weight if BMI \> 30). Dilution are not necessary.

Первичные конечные точки

• proportion of patients with successful intubation at first attempt and without post-induction hypotension [Срок оценки: within 10 minutes after the start of the hypnotic injection]

Вторичные конечные точки (12)

• rates of arterial hypotension episodes [Срок оценки: within 10 minutes after the start of the hypnotic injection]
• rates of tracheal intubation at the first attempt [Срок оценки: within 10 minutes after the start of the hypnotic injection]
• quality of the intubation [Срок оценки: within 10 minutes after the start of the hypnotic injection]
• quality of the intubation [Срок оценки: within 10 minutes after the start of the hypnotic injection]
• rates of vasopressor use and volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room) [Срок оценки: within 10 minutes after the start of the hypnotic injection]
• volume of intravenous fluids for vascular filling [Срок оценки: up to relapse of the recovery room (up to 7 days after surgery)]
• time between administration of hypnotic and tracheal intubation [Срок оценки: within 10 minutes after the start of the hypnotic injection]
• values of heart rate [Срок оценки: within 10 minutes after the start of the hypnotic injection]
• values of SpO2 [Срок оценки: within 10 minutes after the start of the hypnotic injection]
• values of blood pressure [Срок оценки: within 10 minutes after the start of the hypnotic injection]
• rates of pulmonary aspiration of gastric contents [Срок оценки: within 10 minutes after the start of the hypnotic injection]
• Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol [Срок оценки: during stay in the recovery room]

Критерии участия

Критерии включения

• age between 18 - 80 years' old
• female\* and male

• ≥ 1 risk factor of aspiration of gastric contents defined as
• preoperative fasting period of less than 6 hours,
• occlusive syndrome, functional ileus, vomiting episode within the last 12 hours,
• orthopaedic trauma within the last 12 hours,
• medical history of symptomatic gastroesophageal reflux or hiatus, hernia or gastroparesis or dysautonomia or gastroesophageal surgery with sphincter dysfunction)
• patient requiring orotracheal intubation during general anaesthesia in the operating room.
• patient or his/her next of kin written informed consent or emergency procedure
• failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide)

Критерии исключения

• predicted impossible tracheal intubation (≥ 1 of the following criteria: patient with known intubation complications, Mallampati score IV, Thyromental Distance ≤ 4.0 cm, Mouth Opening < 3 cm, Sternomental Distance < 12.5 cm, significant modification of the airway due to congenital, cancer, trauma or burning lesions (non-exhaustive list)) \[30\]
• preoperative arterial hypotension (MAP < 65 mmHg or under catecholamine)
• preoperative respiratory distress syndrome (SpO2 < 90% in room air)
• contraindications to the use of ketamine and/or propofol and/or NMB:

• allergy to the active substance or to one of the excipients or to soy or peanuts,
• porphyria
• intracranial hypertension
• uncontrolled arterial hypertension (systolic arterial pressure > 180 mmHg)
• personal or family history of known malignant hyperthermia, congenital muscular dystrophy, myasthenia, a known congenital deficit in plasma pseudocholinesterase
• pregnancy or breast-feeding woman
• patients under court protection or guardianship
• absence of insurance covering health costs

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 20 центров

• Chr Angers — Angers
• CHRU de Brest Hôpital Cavale Blanche — Brest
• Ch Louis Pasteur — Chartres
• CHU Dijon — Dijon
• CHU Grenoble Alpes — Grenoble
• CHD Vendée — La Roche-sur-Yon
• APHP Bicêtre — Le Kremlin-Bicêtre
• CH Le Mans — Le Mans
• … и ещё 12 центров

Публикации

• Grillot N, Volteau C, Quillet P, Ambrosi X, Caillard A, David JS, Blet A, Bouzat P, Blanchet L, Bruneau N, Chebbi N, Saint-Genis Q, Figueiredo S, Guinot PG, Joosten A, Le Guen M, Labaste F, Lasocki S, Oudot M, Pommier M, Rousseleau D, Verdonk F, Tching-Sin M, Faurel-Paul E, Counille F, Cosse C, Flattres Duchaussoy D, Cinotti R, Roquilly A. Best hypnotic drug choice for rapid sequence induction in PMID 41546091

Идентификаторы

NCT: NCT06733129 · RC24_0389

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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