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

ConditionRapid Sequence Induction

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-80

SponsorNantes University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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)

allergy to the active substance or to one of the excipients or to soy or peanuts,

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

1,218 Participants

are divided into 3 treatment groups

Group A: KETOFOLExperimental treatment 1 intervention

Group B: KETAMINEExperimental treatment 1 intervention

Group C: PROPOFOLActive comparator 1 intervention

Trial outcomes

Primary outcomes

proportion of patients with successful intubation at first attempt and without post-induction hypotension

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.

Time frame