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
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
Treatments tested in this trial
- direct IV injection
- combination of Ketamine and Propofol
Treatment groups
1,218 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov