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

Last updated: April 22, 2025
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

direct IV injection

combination of Ketamine and Propofol

Clinical Study ID

NCT06733129
RC24_0389
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 12hours,

  • orthopaedic trauma within the last 12 hours,

  • medical history of symptomatic gastroesophageal reflux or hiatus, hernia orgastroparesis or dysautonomia or gastroesophageal surgery with sphincterdysfunction)

  • patient requiring orotracheal intubation during general anaesthesia in the operatingroom.

  • patient or his/her next of kin written informed consent or emergency procedure

Exclusion

Exclusion Criteria:

  • predicted impossible tracheal intubation (≥ 1 of the following criteria: patientwith known intubation complications, Mallampati score IV, Thyromental Distance ≤ 4.0cm, Mouth Opening < 3 cm, Sternomental Distance < 12.5 cm, significant modificationof the airway due to congenital, cancer, trauma or burning lesions (non-exhaustivelist)) [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 orpeanuts,

  • porphyria

  • intracranial hypertension

  • uncontrolled arterial hypertension (systolic arterial pressure > 180 mmHg)

  • personal or family history of known malignant hyperthermia, congenital musculardystrophy, myasthenia, a known congenital deficit in plasmapseudocholinesterase

  • pregnancy or breast-feeding woman

  • patients under court protection or guardianship

  • absence of insurance covering health costs

Study Design

Total Participants: 1218
Treatment Group(s): 2
Primary Treatment: direct IV injection
Phase: 3
Study Start date:
April 14, 2025
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Chr Angers

    Angers,
    France

    Site Not Available

  • CHRU de Brest Hôpital Cavale Blanche

    Brest,
    France

    Site Not Available

  • CHU Dijon

    Dijon,
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble,
    France

    Site Not Available

  • CHD Vendée

    La Roche-sur-Yon,
    France

    Site Not Available

  • APHP Bicêtre

    Le Kremlin-Bicêtre,
    France

    Site Not Available

  • CH Le Mans

    Le Mans,
    France

    Site Not Available

  • CHU Lille Hopital Salengro

    Lille,
    France

    Site Not Available

  • CHU Lille Hôpital Claude Huriez

    Lille,
    France

    Site Not Available

  • CHU Lyon Hôpital Sud

    Lyon,
    France

    Site Not Available

  • HCL Lyon Croix-Rousse

    Lyon,
    France

    Site Not Available

  • Chu Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • Chu Nantes (Laennec)

    Nantes, 44093
    France

    Site Not Available

  • APHP St-Antoine

    Paris,
    France

    Site Not Available

  • APHP Tenon

    Paris,
    France

    Site Not Available

  • CHU Poitiers

    Poitiers,
    France

    Site Not Available

  • CHU Toulouse Hôpital Purpan

    Toulouse,
    France

    Site Not Available

  • CHU Toulouse Hôpital Rangueil

    Toulouse,
    France

    Site Not Available

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