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NCT Number: NCT06733129

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

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.

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Key information

Conditions

Rapid Sequence Induction Cardiovascular Diseases Hypotension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chr Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

direct IV injection

Drug

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

combination of Ketamine and Propofol

Drug

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 outcomes

  1. 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

    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.

Secondary outcomes

  1. rates of arterial hypotension episodes

    Time frame: within 10 minutes after the start of the hypnotic injection

    rates of arterial hypotension episodes as defined in primary endpoint within 10 minutes after induction of anaesthesia compared between the three study groups

  2. rates of tracheal intubation at the first attempt

    Time frame: within 10 minutes after the start of the hypnotic injection

    rates of tracheal intubation at the first attempt compared between the three study groups

  3. quality of the intubation

    Time frame: within 10 minutes after the start of the hypnotic injection

    In the operating theatre (within 10 minutes after the start of the hypnotic injection): intubation difficulty scale (IDS-3) values

  4. quality of the intubation

    Time frame: within 10 minutes after the start of the hypnotic injection

    In the operating theatre (within 10 minutes after the start of the hypnotic injection): Cormack-Lehane score values (from 1 to 4)

    • Cormack 1: The glottis is seen in its entirety
    • Cormack 2: Only the posterior half of the glottis is seen
    • Cormack 3: Only a small part of the glottis is seen
    • Cormack 4: The glottis is hidden by the epiglottis and tongue.

  5. 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

    In the operating theatre (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)

  6. volume of intravenous fluids for vascular filling

    Time frame: up to relapse of the recovery room (up to 7 days after surgery)

    volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room)

  7. time between administration of hypnotic and tracheal intubation

    Time frame: within 10 minutes after the start of the hypnotic injection

    Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection) : - time between administration of hypnotic (start of anesthetic induction) and tracheal intubation (defined as the 6th capnography curve)

  8. values of heart rate

    Time frame: within 10 minutes after the start of the hypnotic injection

    Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection) : values of heart rate measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection

  9. values of SpO2

    Time frame: within 10 minutes after the start of the hypnotic injection

    Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): SpO2 measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection

  10. values of blood pressure

    Time frame: within 10 minutes after the start of the hypnotic injection

    Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): systolic/diastolic/mean blood pressure measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection

  11. rates of pulmonary aspiration of gastric contents

    Time frame: within 10 minutes after the start of the hypnotic injection

    Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): rates of pulmonary aspiration of gastric contents during the intubation procedure

  12. Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol

    Time frame: during stay in the recovery room

    Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room by postoperative Nu-DESC (Nursing Delirium Screening Scale) score value compared with preoperative score From 0 to 10

  13. Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol

    Time frame: during stay in the recovery room

    Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room: need of sedative therapy in the recovery room to treat a delirium episode.

  14. Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol

    Time frame: during stay in the recovery room (up to 7 days after induction)

    Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room: Use of ketamine and total dose during intervention and total dose of ketamine in recovery room.

  15. Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol

    Time frame: within 7 days after the start of the hypnotic injection

    Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room:

    Up to day 7:

    • rates of major cardiovascular complications defined as: cardiac arrest, sustained arrhythmia, myocardial infarction, stroke (total, ischaemic, and haemorrhagic), coronary revascularization or admission to ICU for acute heart failure
    • rates of mortality at day 7

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas GRILLOT, MD

CONTACT

[email protected]

02 53 48 22 24 ext. +33

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: HYPNOTIKS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 13, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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