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

Official title

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

Overview

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.

Interventions

• Drug direct IV injection
  direct IV injection at dosage of 2 mg/kg (adjusted body weight if BMI \> 30) after completing pre-oxygenation
• Drug 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.

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 20 centers

• 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
• … and 12 more centers

Publications

• 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

Identifiers

NCT: NCT06733129 · RC24_0389

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗