System Maintenance Notice

Please note that maintenance work is scheduled between 4 AM and 5 AM - CET. During this time, you may experience reduced performance. Thanks for your patience.

Studies

Interventional Recruiting Phase 3

NCT06733129 on ClinicalTrials.gov

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

  • Sponsor: Centre Hospitalier Universitaire de Nantes
  • Enrollment: 1218 (Estimated)
  • Study start: 2025-04-14 (Actual)
  • Primary completion: 2027-04-14 (Estimated)
  • Study completion: 2027-04-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

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.

Conditions

  • Rapid Sequence Induction

Intervention / Treatment

  • Drug: direct IV injection
  • Drug: combination of Ketamine and Propofol

Primary Outcome Measures

  • proportion of patients with successful intubation at first attempt and without post-induction hypotension (within 10 minutes after the start of the hypnotic injection)
    The main objective of the study is to compare the efficacies of ketamine alone and ketamine-propofol combination compared to standard doses of propofol to achieve successful tracheal intubation on the first attempt without hemodynamic hypotension in patients at risk of aspiration of gastric contents in the operating room. The composite primary outcome is the proportion of patients with successful intubation at first attempt and without post-induction hypotension defined by a mean arterial pressure ≤ 60 mmHg within 10 minutes after the start of the hypnotic injection.

Countries

France

Locations and Investigators

  • Centre Hospitalier Universitaire De Toulouse, Toulouse Cedex 9, France
    • François, LABASTE
  • Hospices Civils De Lyon, Pierre Benite, France
    • Stéphane, DAVID
  • Les Hopitaux De Chartres, Le Coudray, France
    • Nidhal, CHEBBI
  • Hospital Foch, Suresnes, France
    • Morgan, LE GUEN
  • Bicetre Hospital, Le Kremlin Bicetre Cedex, France
    • Samy, FIGUEIREDO
  • Centre Hospitalier Departemental Vendee, La Roche Sur Yon Cedex 9, France
    • Mathieu, OUDOT
  • Centre Hospitalier Universitaire De Lille, Lille Cedex, France
    • Nathalie, BRUNEAU
  • Hopital Tenon, Paris Cedex 20, France
    • Franck, VERDONK
  • Centre Hospitalier Universitaire De Nantes, Nantes, France
    • Nicolas, GRILLOT
  • Centre Hospitalier Regional D'Angers, Angers, France
    • Sigismond, LASOCKI
  • Assistance Publique Hopitaux De Paris, Paris, France
    • Franck, VERDONK
  • Centre Hospitalier Regional Et Universitaire De Brest, Brest, France
    • Anais, CAILLARD
  • Centre Hospitalier Universitaire De Lille, Lille, France
    • Cédric, CIRENEI
  • Centre Hospitalier Universitaire De Nantes, Saint Herblain, France
    • Xavier, AMBROSI
  • Centre Hospitalier Universitaire De Toulouse, Toulouse, France
    • Maxime, POMMIER
  • Hospices Civils De Lyon, Lyon Cedex 04, France
    • Alice, BLET
  • Centre Hospitalier Universitaire De Dijon, Dijon, France
  • Hospices Civils De Lyon, Lyon Cedex 04, France
    • Pascal, INFANTINO
  • Centre Hospitalier Le Mans, Le Mans Cedex 9, France
    • Laurent, BLANCHET
  • Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 9, France
    • Pierre, BOUZAT
  • Centre Hospitalier Universitaire De Nantes, Nantes, France
  • Centre Hospitalier Universitaire De Poitiers, Poitiers, France
    • Quentin, SAINT-GENIS