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

Nantes University Hospital (NUH)

Status and phase: Enrolling; Phase 3

Conditions: Rapid Sequence Induction

Treatments: Drug: combination of Ketamine and Propofol; Drug: direct IV injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06733129

RC24_0389

Details and patient eligibility

About

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.

Enrollment: 1,218 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,218 participants in 3 patient groups

KETOFOL

Experimental group

Description:

Ketofol: combination of Ketamine and Propofol : consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg after completing pre-oxygenation

Treatment:

Drug: combination of Ketamine and Propofol

KETAMINE

Experimental group

Description:

direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation

Treatment:

Drug: direct IV injection

PROPOFOL

Active Comparator group

Description:

direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation.

Treatment:

Drug: direct IV injection